Neoplasms, Prostate
Conditions
Keywords
Dutasteride Prostate Cancer Expectant management REDEEM
Brief summary
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
Interventions
DRUGDutasteride
Dutasteride 0.5mg
DRUGMatching placebo
Matching placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must be male ≥48 and ≤82 years of age * Have biopsy proven, low-risk, localized prostate cancer and active in expectant management not more than 14 months. \[For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, (\< 4 cores positive and \<50% of any one core positive) and must have been obtained within 8 months of screening\]. If a saturation biopsy was performed (20 or more cores obtained) 2-3 cores are to be positive for prostate cancer and with \<50% of any one core positive. Initial diagnosis of T1a/T1b obtained during a Transrectal ultrasound (TURP) is not allowed. * Gleason score ≤6 \[Gleason pattern 4 or above must not be present on any biopsy (initial or entry)\] * Clinical stage T1c-T2a * Serum Prostate Specific Antigen (PSA) ≤11ng/mL. If the screening PSA value from the central laboratory is greater than 11ng/ml, one PSA retest is allowed through the central laboratory * A life expectancy greater than five years. * Able to swallow and retain oral medication * Able and willing to participate in the full 3 years of the study * Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.
Exclusion criteria
* Subject has ever been treated for prostate cancer with any of the following: * Radiotherapy (external beam or brachytherapy) * Chemotherapy * Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol (DES) * Oral glucocorticoids * Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin) * Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one * Current and/or previous use of the following medications: * Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry are excluded. * Any other investigational 5α-reductase inhibitors within the past 12 months. * Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible) * Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, \*cimetidine, \*ketoconazole, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the case report form (CRF). \*The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study. * Prostate volume \>80 cc * Subject has had prior prostatic surgery including Transurethral needle ablation of the prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of enrolment * Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions only) of ≥25 or \>20 if already on alpha blocker therapy. * Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period. * Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management. * Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or alkaline phosphatase \[ALP\]); or bilirubin \>1.5 times the upper limit of normal. * Serum creatinine \>1.5 times the upper limit of normal. * History of another malignancy within five years that could affect the diagnosis of prostate cancer. * History or current evidence of drug or alcohol abuse within the last 12 months. * History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject. * Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression | Year 1.5 and Overall (Years 0-3) | PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pathologic Progression | Year 1.5 and Overall (Years 0-3) | Pathological progression is defined as one of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis. |
| Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis | Baseline to Month 18 | All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist. |
| Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy | Years 0-3 | All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory. |
| Number of Cancer-positive Cores in a 12-core Biopsy | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) | All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory. |
| Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) | All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline. |
| Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) | All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100\* number of positive cores/number of evaluated cores). |
| Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) | All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 \* number of positive cores/number of evaluated cores). |
| Cumulative Length of Cancer Tumor Core | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) | All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) \* total tumor length/number of evaluated cores. |
| Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) | All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. |
| Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 | Year 1.5 | The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6). |
| Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | Years 0-3 (Final Biopsy) | The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6). |
| Number of Participants With the Indicated Total Gleason Score | Years 0-3 (Final Biopsy) | All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis. |
| Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline | Baseline | All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen \[PSA\]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate. |
| Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage | Months 0-18 | All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as No Worsening. |
| Number of Participants With Therapeutic Progression | Year 1.5 and Overall (Years 0-3) | Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy. |
| Change From Baseline in Prostate Volume at Years 1.5 and 3 | Baseline and Years 1.5 and 3 | Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements. |
| Percent Change From Baseline in Prostate Volume at Years 1.5 and 3 | Baseline and Years 1.5 and 3 | Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements. |
| Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Baseline and Month 3, 6, 12, 18, and 36 | The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic. |
| Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Baseline and Months 3, 6, 12, 18, and 36 | The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic. |
| Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Baseline and Months 3, 6, 12, 18, and 36 | The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9. |
| Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Baseline and Months 3, 6, 12, 18, and 36 | The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9. |
| Total MAX-PC Fear of Recurrence Subscale Score | Baseline and Months 3, 6, 12, 18, and 36 | The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12. |
| Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Baseline and Months 3, 6, 12, 18, and 36 | The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12. |
| Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | Baseline and Months 18 and 36 | The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life. |
| Change From Baseline in Total FACT-P Score (LOCF) | Baseline and Months 18 and 36 | The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL. |
| Percent Change From Baseline in Total FACT-P Score (LOCF) | Baseline and Months 18 and 36 | The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL. |
| Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) | Baseline and Months 18 and 36 | The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I have a lack of energy., I have nausea., Because of my physical condition, I have trouble meeting the needs of my family., I have pain., I am bothered by side effects of treatment., I feel ill., I am forced to spend time in bed. The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life. |
| Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) | Baseline and Months 18 and 36 | The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I feel close to my friends., I get emotional support from my family., I get support from my friends., My family has accepted my illness., I am satisfied with family communication about my illness., I feel close to my partner (or the person who is my main support)., I am satisfied with my sex life. The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156. |
| Prostate Volume (PV) LOCF | Baseline and Years 1.5 and 3 | Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements. |
Countries
Canada, United States
Participant flow
Pre-assignment details
A completed participant is defined as one who completed the 36-month treatment phase of the study and the 4-month safety follow-up phase.
Participants by arm
| Arm | Count |
|---|---|
| Matching Placebo 0.5 mg Once Daily Matching placebo 0.5 mg administered orally once daily for 156 weeks | 155 |
| Dutasteride 0.5 mg Once Daily Dutasteride 0.5 mg administered orally once daily for 156 weeks | 147 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 |
| Overall Study | Disease Progression | 46 | 26 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Non-Compliance | 1 | 1 |
| Overall Study | Participant Moved to Another Country | 1 | 0 |
| Overall Study | Participant Moved to Louisiana | 0 | 1 |
| Overall Study | Participant Opted for Treatment | 1 | 0 |
| Overall Study | Participant Refused Biopsy | 1 | 0 |
| Overall Study | Participant Withdrew Waiting for Surgery | 0 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Prostate Volume/PSA Doubled | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Sponsor Terminated Study | 2 | 2 |
| Overall Study | Withdrawal by Subject | 12 | 6 |
| Overall Study | Withdrawn per Instructions of Monitor | 0 | 1 |
Baseline characteristics
| Characteristic | Matching Placebo 0.5 mg Once Daily | Dutasteride 0.5 mg Once Daily | Total |
|---|---|---|---|
| Age, Continuous | 65.0 Years STANDARD_DEVIATION 7.56 | 65.1 Years STANDARD_DEVIATION 7.13 | 65.0 Years STANDARD_DEVIATION 7.34 |
| Gender Female | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 155 Participants | 147 Participants | 302 Participants |
| Race/Ethnicity, Customized African American | 12 participants | 8 participants | 20 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 4 participants | 5 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 141 participants | 132 participants | 273 participants |
| Race/Ethnicity, Customized White and American Indian/Alaskan Native | 0 participants | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / 155 | 56 / 147 |
| serious Total, serious adverse events | 23 / 155 | 22 / 147 |
Outcome results
Primary
Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.
Time frame: Year 1.5 and Overall (Years 0-3)
Population: ITT Population: all participants randomized to study treatment. Some participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression | Year 1.5, n=144, 142 | 50 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression | Overall (Years 0-3), n= 155, 147 | 71 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression | Year 1.5, n=144, 142 | 32 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression | Overall (Years 0-3), n= 155, 147 | 54 participants |
p-value: 0.00995% CI: [0.36, 0.87]Log Rank
p-value: 0.00795% CI: [0.43, 0.88]Log Rank
Secondary
Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)
The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I have a lack of energy., I have nausea., Because of my physical condition, I have trouble meeting the needs of my family., I have pain., I am bothered by side effects of treatment., I feel ill., I am forced to spend time in bed. The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life.
Time frame: Baseline and Months 18 and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) | Month 18, n=148, 140 | -0.4 points on a scale | Standard Deviation 2.48 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) | Month 36, n=149, 140 | -0.3 points on a scale | Standard Deviation 2.65 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) | Month 18, n=148, 140 | -0.2 points on a scale | Standard Deviation 2.28 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) | Month 36, n=149, 140 | -0.3 points on a scale | Standard Deviation 2.58 |
Secondary
Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)
The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I feel close to my friends., I get emotional support from my family., I get support from my friends., My family has accepted my illness., I am satisfied with family communication about my illness., I feel close to my partner (or the person who is my main support)., I am satisfied with my sex life. The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156.
Time frame: Baseline and Months 18 and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) | Month 18, n=148, 140 | -1.4 points on a scale | Standard Deviation 5.32 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) | Month 36, n=149, 140 | -1.1 points on a scale | Standard Deviation 6.04 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) | Month 18, n=148, 140 | -0.6 points on a scale | Standard Deviation 5.95 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) | Month 36, n=149, 140 | -1.2 points on a scale | Standard Deviation 6.59 |
Secondary
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.
Time frame: Baseline and Months 3, 6, 12, 18, and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 3 | 0.7 points on a scale | Standard Deviation 4.51 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 6 | 0.1 points on a scale | Standard Deviation 5.08 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 12 | 0.1 points on a scale | Standard Deviation 5.28 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 18 | -0.2 points on a scale | Standard Deviation 5.4 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 18 Take-Home | 0.3 points on a scale | Standard Deviation 6.1 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 36 Take-Home | 0.5 points on a scale | Standard Deviation 5.99 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 36 | 0.4 points on a scale | Standard Deviation 5.8 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 18 | -0.8 points on a scale | Standard Deviation 6.08 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 3 | 0.3 points on a scale | Standard Deviation 5.12 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 36 Take-Home | -1.0 points on a scale | Standard Deviation 5.91 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 6 | -0.3 points on a scale | Standard Deviation 5.53 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 18 Take-Home | -0.1 points on a scale | Standard Deviation 6.32 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 12 | -0.6 points on a scale | Standard Deviation 5.76 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | Month 36 | -0.7 points on a scale | Standard Deviation 5.97 |
Secondary
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.
Time frame: Baseline and Months 3, 6, 12, 18, and 36
Population: ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 3, n=146, 143 | -0.2 points on a scale | Standard Deviation 2.07 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 36, n=148, 143 | 0.0 points on a scale | Standard Deviation 2.32 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 6, n= 148, 143 | -0.2 points on a scale | Standard Deviation 2.15 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 12, n=148, 143 | -0.1 points on a scale | Standard Deviation 2.38 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 18, n=148, 143 | -0.1 points on a scale | Standard Deviation 2.34 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 18 Take-Home, n=148, 143 | 0.0 points on a scale | Standard Deviation 2.35 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 36 Take-Home, n=148, 143 | 0.0 points on a scale | Standard Deviation 2.56 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 6, n= 148, 143 | -0.5 points on a scale | Standard Deviation 2.13 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 18 Take-Home, n=148, 143 | -0.3 points on a scale | Standard Deviation 2.56 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 18, n=148, 143 | -0.7 points on a scale | Standard Deviation 2.31 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 36, n=148, 143 | -0.6 points on a scale | Standard Deviation 2.64 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 36 Take-Home, n=148, 143 | -0.7 points on a scale | Standard Deviation 2.55 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 3, n=146, 143 | -0.0 points on a scale | Standard Deviation 2.19 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | Month 12, n=148, 143 | -0.7 points on a scale | Standard Deviation 2.24 |
Secondary
Change From Baseline in Prostate Volume at Years 1.5 and 3
Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements.
Time frame: Baseline and Years 1.5 and 3
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 1.5, n=117, 117 | 0.7 cc | Standard Deviation 11.7 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 3, n=118, 118 | 3.3 cc | Standard Deviation 11.95 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 1.5, n=117, 117 | -9.5 cc | Standard Deviation 10.51 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 3, n=118, 118 | -8.6 cc | Standard Deviation 10.89 |
Secondary
Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.
Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 | Year 1.5, n= 87, 99 | 3.9 millimeters | Standard Deviation 5.71 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 | Year 3, n=52, 54 | 1.8 millimeters | Standard Deviation 3.94 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 | Years 0-3 (Final biopsy), n=105, 90 | 4.8 millimeters | Standard Deviation 6.7 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 | Year 1.5, n= 87, 99 | 2.5 millimeters | Standard Deviation 6.59 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 | Year 3, n=52, 54 | 1.5 millimeters | Standard Deviation 3.58 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 | Years 0-3 (Final biopsy), n=105, 90 | 3.8 millimeters | Standard Deviation 6.27 |
Secondary
Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.
Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 1.5, n= 87, 99 | 1.1 cores | Standard Deviation 1.63 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 3, n=52, 54 | 2.0 cores | Standard Deviation 1.17 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Years 0-3 (Final biopsy), n=105, 90 | 3.0 cores | Standard Deviation 2.03 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 1.5, n= 87, 99 | 0.6 cores | Standard Deviation 1.36 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 3, n=52, 54 | 2.0 cores | Standard Deviation 0.95 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Years 0-3 (Final biopsy), n=105, 90 | 2.5 cores | Standard Deviation 1.25 |
Secondary
Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 \* number of positive cores/number of evaluated cores).
Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 1.5, n= 87, 99 | 8.4 percentage of cores | Standard Deviation 13.73 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 3, n=52, 54 | 4.1 percentage of cores | Standard Deviation 9.84 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Years 0-3 (Final biopsy), n=105, 90 | 10.0 percentage of cores | Standard Deviation 13.88 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 1.5, n= 87, 99 | 3.7 percentage of cores | Standard Deviation 11.97 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Year 3, n=52, 54 | 1.5 percentage of cores | Standard Deviation 10.03 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 | Years 0-3 (Final biopsy), n=105, 90 | 6.0 percentage of cores | Standard Deviation 11.4 |
Secondary
Change From Baseline in Total FACT-P Score (LOCF)
The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.
Time frame: Baseline and Months 18 and 36
Population: ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total FACT-P Score (LOCF) | Month 18, n=144, 140 | -4.2 points on a scale | Standard Deviation 11.89 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total FACT-P Score (LOCF) | Month 36, n=148, 140 | -3.7 points on a scale | Standard Deviation 15.55 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total FACT-P Score (LOCF) | Month 36, n=148, 140 | -2.3 points on a scale | Standard Deviation 15.74 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total FACT-P Score (LOCF) | Month 18, n=144, 140 | -1.2 points on a scale | Standard Deviation 14.61 |
Secondary
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.
Time frame: Baseline and Months 3, 6, 12, 18, and 36
Population: ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 18 Take-Home, n=148, 143 | 0.6 points on a scale | Standard Deviation 8.39 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 12, n=148, 143 | -0.1 points on a scale | Standard Deviation 7.2 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 36, n=148, 143 | 0.5 points on a scale | Standard Deviation 8.17 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 36 Take-Home, n=148, 143 | 0.7 points on a scale | Standard Deviation 8.66 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 6, n=148, 143 | -0.0 points on a scale | Standard Deviation 6.79 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 18, n=148, 143 | -0.3 points on a scale | Standard Deviation 7.57 |
| Matching Placebo 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 3, n=146, 143 | 0.4 points on a scale | Standard Deviation 5.86 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 6, n=148, 143 | -0.8 points on a scale | Standard Deviation 7.15 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 3, n=146, 143 | 0.3 points on a scale | Standard Deviation 7.04 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 36 Take-Home, n=148, 143 | -1.8 points on a scale | Standard Deviation 8.22 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 12, n=148, 143 | -1.4 points on a scale | Standard Deviation 7.58 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 18 Take-Home, n=148, 143 | -0.6 points on a scale | Standard Deviation 8.45 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 18, n=148, 143 | -1.6 points on a scale | Standard Deviation 8.25 |
| Dutasteride 0.5 mg Once Daily | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | Month 36, n=148, 143 | -1.5 points on a scale | Standard Deviation 8.3 |
Secondary
Cumulative Length of Cancer Tumor Core
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) \* total tumor length/number of evaluated cores.
Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Baseline, n= 155, 147 | 2.0 millimeters | Standard Deviation 1.86 |
| Matching Placebo 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Year 1.5, n=87, 99 | 6.2 millimeters | Standard Deviation 5.99 |
| Matching Placebo 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Year 3, n=52, 54 | 3.7 millimeters | Standard Deviation 3.82 |
| Matching Placebo 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Years 0-3 (Final biopsy), n=105, 90 | 7.0 millimeters | Standard Deviation 7.02 |
| Dutasteride 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Years 0-3 (Final biopsy), n=105, 90 | 6.1 millimeters | Standard Deviation 6.19 |
| Dutasteride 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Baseline, n= 155, 147 | 2.1 millimeters | Standard Deviation 2.04 |
| Dutasteride 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Year 3, n=52, 54 | 3.8 millimeters | Standard Deviation 3.51 |
| Dutasteride 0.5 mg Once Daily | Cumulative Length of Cancer Tumor Core | Year 1.5, n=87, 99 | 4.8 millimeters | Standard Deviation 6.34 |
Secondary
Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100\* number of positive cores/number of evaluated cores).
Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Baseline, n= 155, 147 | 14.3 percentage of cores | Standard Deviation 7.3 |
| Matching Placebo 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Year 1.5, n=87, 99 | 23.7 percentage of cores | Standard Deviation 15.76 |
| Matching Placebo 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Year 3, n=52, 54 | 16.5 percentage of cores | Standard Deviation 9.71 |
| Matching Placebo 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Years 0-3 (Final biopsy), n=105, 90 | 24.7 percentage of cores | Standard Deviation 15.66 |
| Dutasteride 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Years 0-3 (Final biopsy), n=105, 90 | 21.7 percentage of cores | Standard Deviation 10.76 |
| Dutasteride 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Baseline, n= 155, 147 | 14.5 percentage of cores | Standard Deviation 6.95 |
| Dutasteride 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Year 3, n=52, 54 | 17.3 percentage of cores | Standard Deviation 8.44 |
| Dutasteride 0.5 mg Once Daily | Mean Percentage of Cancer-positive Cores in a 12-core Biopsy | Year 1.5, n=87, 99 | 19.0 percentage of cores | Standard Deviation 10.66 |
Secondary
Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline
All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen \[PSA\]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.
Time frame: Baseline
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline | T1c | 125 biopsies |
| Matching Placebo 0.5 mg Once Daily | Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline | T2a | 30 biopsies |
| Matching Placebo 0.5 mg Once Daily | Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline | T2c | 0 biopsies |
| Dutasteride 0.5 mg Once Daily | Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline | T2c | 1 biopsies |
| Dutasteride 0.5 mg Once Daily | Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline | T1c | 117 biopsies |
| Dutasteride 0.5 mg Once Daily | Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline | T2a | 29 biopsies |
p-value: 0.8Wilcoxon (Mann-Whitney)
Secondary
Number of Cancer-positive Cores in a 12-core Biopsy
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.
Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Year 1.5, n=87, 99 | 2.8 cores | Standard Deviation 1.82 |
| Matching Placebo 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Baseline, n=155, 147 | 1.6 cores | Standard Deviation 0.74 |
| Matching Placebo 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Year 3, n=52, 54 | 2.0 cores | Standard Deviation 1.17 |
| Matching Placebo 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Years 0-3 (Final biopsy), n=105, 90 | 3.0 cores | Standard Deviation 2.03 |
| Dutasteride 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Years 0-3 (Final biopsy), n=105, 90 | 2.5 cores | Standard Deviation 1.25 |
| Dutasteride 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Baseline, n=155, 147 | 1.6 cores | Standard Deviation 0.72 |
| Dutasteride 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Year 1.5, n=87, 99 | 2.2 cores | Standard Deviation 1.25 |
| Dutasteride 0.5 mg Once Daily | Number of Cancer-positive Cores in a 12-core Biopsy | Year 3, n=52, 54 | 2.0 cores | Standard Deviation 0.95 |
Secondary
Number of Participants With Pathologic Progression
Pathological progression is defined as one of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.
Time frame: Year 1.5 and Overall (Years 0-3)
Population: ITT Population. As the study progressed, participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Participants With Pathologic Progression | Year 1.5, n= 136, 139 | 39 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With Pathologic Progression | Overall (Years 0-3) n=136, 140 | 51 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With Pathologic Progression | Year 1.5, n= 136, 139 | 27 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With Pathologic Progression | Overall (Years 0-3) n=136, 140 | 43 participants |
p-value: 0.03195% CI: [0.36, 0.96]Log Rank
p-value: 0.07995% CI: [0.46, 1.05]Log Rank
Secondary
Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5
The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6).
Time frame: Year 1.5
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 | Improvement | 6 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 | No change | 51 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 | Worsening | 24 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 | No change | 58 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 | Worsening | 21 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 | Improvement | 21 participants |
p-value: 0.2Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6).
Time frame: Years 0-3 (Final Biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | Worsening | 22 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | No cancer, GS 0 | 31 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | No change | 83 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | Improvement | 31 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | No change | 71 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | Worsening | 19 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | Improvement | 50 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | No cancer, GS 0 | 50 participants |
p-value: 0.039Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With the Indicated Total Gleason Score
All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.
Time frame: Years 0-3 (Final Biopsy)
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 9-10 | 0 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 7, 3 (primary grade) + 4 (secondary grade) | 15 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 5 | 0 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 7, 4 (primary grade) + 3 (secondary grade) | 4 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 6 | 83 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 8 | 3 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | Missing (No Cancer) | 31 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 8 | 2 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | Missing (No Cancer) | 50 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 5 | 0 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 9-10 | 0 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 6 | 71 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 7, 3 (primary grade) + 4 (secondary grade) | 13 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With the Indicated Total Gleason Score | GS 7, 4 (primary grade) + 3 (secondary grade) | 4 participants |
Secondary
Number of Participants With Therapeutic Progression
Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.
Time frame: Year 1.5 and Overall (Years 0-3)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Participants With Therapeutic Progression | Year 1.5 | 11 participants |
| Matching Placebo 0.5 mg Once Daily | Number of Participants With Therapeutic Progression | Overall (Years 0-3) | 20 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With Therapeutic Progression | Year 1.5 | 5 participants |
| Dutasteride 0.5 mg Once Daily | Number of Participants With Therapeutic Progression | Overall (Years 0-3) | 11 participants |
p-value: 0.1395% CI: [0.16, 1.31]Log Rank
p-value: 0.05395% CI: [0.22, 1.03]Log Rank
Secondary
Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage
All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as No Worsening.
Time frame: Months 0-18
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage | No Worsening (same/lower stage) | 53 biopsies |
| Matching Placebo 0.5 mg Once Daily | Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage | Worsening (higher stage) | 13 biopsies |
| Dutasteride 0.5 mg Once Daily | Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage | No Worsening (same/lower stage) | 53 biopsies |
| Dutasteride 0.5 mg Once Daily | Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage | Worsening (higher stage) | 5 biopsies |
p-value: 0.12Fisher Exact
Secondary
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis
All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.
Time frame: Baseline to Month 18
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis | Participants with a PCa diagnosis | 111 participants |
| Matching Placebo 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis | Participants with no PCa diagnosis | 25 participants |
| Dutasteride 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis | Participants with a PCa diagnosis | 111 participants |
| Dutasteride 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis | Participants with no PCa diagnosis | 29 participants |
p-value: 0.65Fisher Exact
Secondary
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.
Time frame: Years 0-3
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy | Participants with a PCa diagnosis | 105 participants |
| Matching Placebo 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy | Participants with no PCa diagnosis | 31 participants |
| Dutasteride 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy | Participants with a PCa diagnosis | 90 participants |
| Dutasteride 0.5 mg Once Daily | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy | Participants with no PCa diagnosis | 50 participants |
p-value: 0.024Fisher Exact
Secondary
Percent Change From Baseline in Prostate Volume at Years 1.5 and 3
Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.
Time frame: Baseline and Years 1.5 and 3
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Percent Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 1.5, n=117, 117 | 3.7 percent change | Standard Deviation 25.24 |
| Matching Placebo 0.5 mg Once Daily | Percent Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 3, n=118, 118 | 7.7 percent change | Standard Deviation 25.64 |
| Dutasteride 0.5 mg Once Daily | Percent Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 1.5, n=117, 117 | -19.8 percent change | Standard Deviation 26.9 |
| Dutasteride 0.5 mg Once Daily | Percent Change From Baseline in Prostate Volume at Years 1.5 and 3 | Year 3, n=118, 118 | -18.0 percent change | Standard Deviation 27.98 |
Secondary
Percent Change From Baseline in Total FACT-P Score (LOCF)
The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.
Time frame: Baseline and Months 18 and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Percent Change From Baseline in Total FACT-P Score (LOCF) | Month 18, n=144, 140 | -2.8 points on a scale | Standard Deviation 10.49 |
| Matching Placebo 0.5 mg Once Daily | Percent Change From Baseline in Total FACT-P Score (LOCF) | Month 36, n=148, 140 | -1.8 points on a scale | Standard Deviation 16.39 |
| Dutasteride 0.5 mg Once Daily | Percent Change From Baseline in Total FACT-P Score (LOCF) | Month 36, n=148, 140 | -1.0 points on a scale | Standard Deviation 14.16 |
| Dutasteride 0.5 mg Once Daily | Percent Change From Baseline in Total FACT-P Score (LOCF) | Month 18, n=144, 140 | -0.2 points on a scale | Standard Deviation 13.44 |
Secondary
Prostate Volume (PV) LOCF
Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.
Time frame: Baseline and Years 1.5 and 3
Population: ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Prostate Volume (PV) LOCF | Baseline, n=133, 126 | 44.2 cubic centimeters (cc) | Standard Deviation 19.17 |
| Matching Placebo 0.5 mg Once Daily | Prostate Volume (PV) LOCF | Year 1.5, n=117, 117 | 43.1 cubic centimeters (cc) | Standard Deviation 17.97 |
| Matching Placebo 0.5 mg Once Daily | Prostate Volume (PV) LOCF | Year 3, n=118, 118 | 43.0 cubic centimeters (cc) | Standard Deviation 17.94 |
| Dutasteride 0.5 mg Once Daily | Prostate Volume (PV) LOCF | Baseline, n=133, 126 | 43.2 cubic centimeters (cc) | Standard Deviation 15.32 |
| Dutasteride 0.5 mg Once Daily | Prostate Volume (PV) LOCF | Year 1.5, n=117, 117 | 43.3 cubic centimeters (cc) | Standard Deviation 15.12 |
| Dutasteride 0.5 mg Once Daily | Prostate Volume (PV) LOCF | Year 3, n=118, 118 | 43.1 cubic centimeters (cc) | Standard Deviation 15.24 |
Secondary
Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.
Time frame: Baseline and Months 18 and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | Baseline, n=154, 145 | 129.9 points on a scale | Standard Deviation 17.45 |
| Matching Placebo 0.5 mg Once Daily | Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | Month 18, n=145, 140 | 126.9 points on a scale | Standard Deviation 16.03 |
| Matching Placebo 0.5 mg Once Daily | Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | Month 36, n=149, 140 | 126.6 points on a scale | Standard Deviation 17 |
| Dutasteride 0.5 mg Once Daily | Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | Baseline, n=154, 145 | 131.3 points on a scale | Standard Deviation 15.07 |
| Dutasteride 0.5 mg Once Daily | Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | Month 18, n=145, 140 | 130.2 points on a scale | Standard Deviation 16.29 |
| Dutasteride 0.5 mg Once Daily | Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | Month 36, n=149, 140 | 129.0 points on a scale | Standard Deviation 16.85 |
Secondary
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.
Time frame: Baseline and Months 3, 6, 12, 18, and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 36 Take-Home, n=152, 144 | 7.4 points on a scale | Standard Deviation 6.64 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 12, n=152, 144 | 7.0 points on a scale | Standard Deviation 6.27 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 18, n=152, 144 | 6.7 points on a scale | Standard Deviation 6.25 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 3, n=152, 144 | 7.5 points on a scale | Standard Deviation 6.16 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 18 Take-Home, n=152, 144 | 7.2 points on a scale | Standard Deviation 6.75 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Baseline, n=154, 147 | 7.1 points on a scale | Standard Deviation 6.55 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 36, n=152,144 | 7.3 points on a scale | Standard Deviation 6.58 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 6, n=152, 144 | 7.0 points on a scale | Standard Deviation 6.49 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 36, n=152,144 | 6.5 points on a scale | Standard Deviation 6.72 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 36 Take-Home, n=152, 144 | 6.2 points on a scale | Standard Deviation 6.95 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Baseline, n=154, 147 | 7.3 points on a scale | Standard Deviation 6.35 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 3, n=152, 144 | 7.5 points on a scale | Standard Deviation 6.95 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 6, n=152, 144 | 6.9 points on a scale | Standard Deviation 6.6 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 18, n=152, 144 | 6.4 points on a scale | Standard Deviation 6.78 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 18 Take-Home, n=152, 144 | 7.1 points on a scale | Standard Deviation 7.1 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | Month 12, n=152, 144 | 6.6 points on a scale | Standard Deviation 6.46 |
Secondary
Total MAX-PC Fear of Recurrence Subscale Score
The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.
Time frame: Baseline and Months 3, 6, 12, 18, and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 12, n=152, 144 | 3.2 points on a scale | Standard Deviation 2.51 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 6, n=152, 144 | 3.3 points on a scale | Standard Deviation 2.57 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 36, n=152, 144 | 3.4 points on a scale | Standard Deviation 2.67 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 18, n=152, 144 | 3.3 points on a scale | Standard Deviation 2.52 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 3, n=150, 144 | 3.2 points on a scale | Standard Deviation 2.59 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 18 Take-Home, n=152, 144 | 3.4 points on a scale | Standard Deviation 2.49 |
| Matching Placebo 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Baseline, n=151, 146 | 3.4 points on a scale | Standard Deviation 2.51 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 18 Take-Home, n=152, 144 | 3.0 points on a scale | Standard Deviation 2.7 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Baseline, n=151, 146 | 3.4 points on a scale | Standard Deviation 2.4 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 6, n=152, 144 | 2.9 points on a scale | Standard Deviation 2.39 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 36, n=152, 144 | 2.7 points on a scale | Standard Deviation 2.65 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 3, n=150, 144 | 3.3 points on a scale | Standard Deviation 2.66 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 12, n=152, 144 | 2.6 points on a scale | Standard Deviation 2.37 |
| Dutasteride 0.5 mg Once Daily | Total MAX-PC Fear of Recurrence Subscale Score | Month 18, n=152, 144 | 2.7 points on a scale | Standard Deviation 2.5 |
Secondary
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.
Time frame: Baseline and Month 3, 6, 12, 18, and 36
Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Baseline, n=151, 146 | 11.0 points on a scale | Standard Deviation 9.28 |
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 3, n=150, 144 | 11.4 points on a scale | Standard Deviation 8.8 |
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 6, n=152, 144 | 10.9 points on a scale | Standard Deviation 9.01 |
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 12, n=152, 144 | 10.7 points on a scale | Standard Deviation 8.82 |
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 36, n=152, 144 | 11.3 points on a scale | Standard Deviation 9.56 |
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 36 Take-Home, n=152, 144 | 11.5 points on a scale | Standard Deviation 9.68 |
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 18, n=152, 144 | 10.5 points on a scale | Standard Deviation 8.96 |
| Matching Placebo 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 18 Take-Home, n=152, 144 | 11.4 points on a scale | Standard Deviation 9.53 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 18, n=152, 144 | 9.5 points on a scale | Standard Deviation 9.43 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Baseline, n=151, 146 | 11.3 points on a scale | Standard Deviation 8.84 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 36, n=152, 144 | 9.6 points on a scale | Standard Deviation 9.75 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 3, n=150, 144 | 11.4 points on a scale | Standard Deviation 9.71 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 36 Take-Home, n=152, 144 | 9.4 points on a scale | Standard Deviation 9.85 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 6, n=152, 144 | 10.4 points on a scale | Standard Deviation 9.33 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 18 Take-Home, n=152, 144 | 10.6 points on a scale | Standard Deviation 9.98 |
| Dutasteride 0.5 mg Once Daily | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | Month 12, n=152, 144 | 9.7 points on a scale | Standard Deviation 8.93 |