Neoplasms, Prostate
Conditions
Keywords
Prostate cancer prevention, prostate, BPH, enlarged prostate, PSA, prostate cancer
Brief summary
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
Interventions
DRUGDutasteride
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.
DRUGPlacebo
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent to participate in study. * Have had a single negative prostate biopsy within 6 months prior to enrollment in study. * Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60. * Ability and will to participate in study for 4 years.
Exclusion criteria
* More than one previous negative prostate biopsy. * History of prostate cancer. * Previous prostate surgery. * Inability to urinate requiring the need of a catheter during the previous 2 years. * Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate. * Cancer within previous 5 years (other than basal or squamous cell cancers of the skin). * Any unstable serious medical condition. * Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) | Years 1-2, Years 3-4, and Overall (Years 1-4) | Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia\[HGPIN\] or typical small acinar proliferation \[ASAP\]) and prostate surgeries were reviewed by the lead pathologist. |
| Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) | Years 1-2, Years 3-4, and Overall (Years 1-4) | Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42. |
| Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) | Years 1-2, Years 3-4, and Overall (Years 1-4) | Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Core Involved at Diagnosis | Baseline to Year 4 | The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample. |
| Number of Cancer-positive Cores | Baseline to Year 4 | The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant. |
| Treatment Alteration Score | Baseline to Year 4 | The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes. |
| Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment | Baseline to Year 4 | The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy). |
| Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48 | Baseline to Year 4 (Month 48) | The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment. |
| Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48 | Baseline, Month 24, and Month 48 | Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value). |
| Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers. |
| Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms | Years 1-2, Overall (Years 1-4) | Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit. |
| Number of Participants With at Least One Event of Acute Urinary Retention (AUR) | Years 1-2 and Overall (Years 1-4) | A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study. |
| Number of Participants With at Least One Urinary Tract Infection (UTI) | Years 1-2, Years 3-4, and Overall (Years 1-4) | A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study. |
| Number of Participants With the Indicated Gleason Score at Diagnosis | Baseline to Year 4 | Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10. |
| Number of Participants With Post-biopsy Macroscopic Hematospermia | Baseline through Year 4 | Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study. |
| Overall Survival | From time informed consent is signed to 4-month Safety Follow-Up period | Overall survival is assessed as the number of deaths reported throughout the study. |
| Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48 | Baseline and Month 48 | The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment. |
| Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48 | Baseline and Month 48 | The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment. |
| Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48 | Baseline and Month 48 | The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment. |
| Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48 | Baseline and Month 48 | The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment. |
| Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48 | Baseline and Month 48 | The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment. |
| Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48 | Month 48 | Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter. |
| Mean Change From Baseline in Testosterone at Month 48 | Baseline and Month 48 | Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter. |
| Number of Participants With Post-biopsy Macroscopic Hematuria | Baseline to Year 4 | Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study. |
| Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | Baseline to Year 4 | The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category (HGPIN or prostate cancer diagnosis) and again in the last category (HGPIN, ASAP, or prostate cancer diagnosis). |
| Volume of HGPIN at Biopsy | Baseline to Year 4 | The amount of prostate biopsy tissue with HGPIN was measured. |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules. | 4,126 |
| Dutasteride 0.5 mg Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule. | 4,105 |
| Total | 8,231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 282 | 364 |
| Overall Study | Diagnosed with Prostate Cancer | 202 | 166 |
| Overall Study | Listed as Other on Case Report Form | 98 | 60 |
| Overall Study | Lost to Follow-up | 123 | 113 |
| Overall Study | Missing | 25 | 34 |
| Overall Study | Protocol Violation | 104 | 95 |
| Overall Study | Withdrawal by Subject | 377 | 361 |
Baseline characteristics
| Characteristic | Placebo | Dutasteride 0.5 mg | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 6.08 | 62.8 years STANDARD_DEVIATION 6.04 | 62.8 years STANDARD_DEVIATION 6.06 |
| Race/Ethnicity, Customized American Hispanic | 173 participants | 160 participants | 333 participants |
| Race/Ethnicity, Customized Asian | 67 participants | 67 participants | 134 participants |
| Race/Ethnicity, Customized Black | 99 participants | 91 participants | 190 participants |
| Race/Ethnicity, Customized Missing | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 39 participants | 43 participants | 82 participants |
| Race/Ethnicity, Customized White | 3747 participants | 3744 participants | 7491 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4126 Participants | 4105 Participants | 8231 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1,151 / 4,126 | 1,296 / 4,105 |
| serious Total, serious adverse events | 837 / 4,126 | 748 / 4,105 |
Outcome results
Primary
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia\[HGPIN\] or typical small acinar proliferation \[ASAP\]) and prostate surgeries were reviewed by the lead pathologist.
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Population: Efficacy Population: all randomized participants with a negative entry biopsy, as determined by the CPL, who received at least 1 dose of study drug. The crude rate approach included all participants at risk at the beginning of each time period .
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) | Years 3- 4, n=2815, 2844 | 280 participants |
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) | Years 1- 2, n=4073, 4049 | 578 participants |
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) | Overall, n=4073, 4049 | 858 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) | Years 1- 2, n=4073, 4049 | 435 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) | Years 3- 4, n=2815, 2844 | 224 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) | Overall, n=4073, 4049 | 659 participants |
p-value: <0.000195% CI: [15.6, 30.3]Mantel-Cox
Primary
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Population: Efficacy Population, modified crude rate: participants who either were diagnosed with prostate cancer during the study or had an end of time period biopsy. N for each time period is the number who either had at least 1 biopsy in the final 6 months of the time period or had a positive biopsy anytime during the time period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) | Years 1-2, n=3319, 3209 | 578 participants |
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) | Years 3-4, n=2325, 2434 | 280 participants |
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) | Overall, n=2903, 2869 | 858 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) | Years 3-4, n=2325, 2434 | 224 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) | Years 1-2, n=3319, 3209 | 435 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) | Overall, n=2903, 2869 | 659 participants |
p-value: <0.000195% CI: [15.5, 30]Mantel-Cox
Primary
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Population: Efficacy Population, restricted crude rate: the number of prostate cancer events is based on the the number of participants who had at least one biopsy during the time period. Ns at Years 1-2 and Years 3-4 are the number who had a biopsy in those time periods; the overall n is the number of participants who had 1 or more biopsy during Years 1-4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) | Years 1-2, n=3364, 3244 | 578 participants |
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) | Years 3- 4, n=2359, 2451 | 280 participants |
| Placebo | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) | Overall, n=3424, 3305 | 858 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) | Years 1-2, n=3364, 3244 | 435 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) | Years 3- 4, n=2359, 2451 | 224 participants |
| Dutasteride 0.5 mg | Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) | Overall, n=3424, 3305 | 659 participants |
p-value: <0.000195% CI: [15.2, 29.8]Mantel-Cox
Secondary
Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48
Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 12, n=1178, 1168 | -0.55 milliliters/second | Standard Error 0.253 |
| Placebo | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 24, n=1337, 1295 | -0.63 milliliters/second | Standard Error 0.41 |
| Placebo | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 36, n=1375, 1334 | -0.74 milliliters/second | Standard Error 0.238 |
| Placebo | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 48, n=1390, 1359 | -0.90 milliliters/second | Standard Error 0.303 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 48, n=1390, 1359 | 0.41 milliliters/second | Standard Error 0.307 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 12, n=1178, 1168 | 0.27 milliliters/second | Standard Error 0.255 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 36, n=1375, 1334 | 0.13 milliliters/second | Standard Error 0.241 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 | Month 24, n=1337, 1295 | 0.60 milliliters/second | Standard Error 0.416 |
Secondary
Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48
The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.
Time frame: Baseline and Month 48
Population: Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48 | -0.06 points on a scale | Standard Error 0.018 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48 | -0.33 points on a scale | Standard Error 0.018 |
Secondary
Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48
The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.
Time frame: Baseline and Month 48
Population: Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48 | 0.44 points on a scale | Standard Error 0.037 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48 | -0.21 points on a scale | Standard Error 0.037 |
Secondary
Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48
The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.
Time frame: Baseline to Year 4 (Month 48)
Population: Efficacy Population, last observation carried forward (LOCF). In the LOCF approach, missing values at post-baseline assessments are replaced with the participant's previous non-missing post-baseline assessment. The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48 | 1.35 points on a scale | Standard Error 0.087 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48 | -0.46 points on a scale | Standard Error 0.087 |
Secondary
Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48
The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.
Time frame: Baseline and Month 48
Population: Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48 | -0.03 points on a scale | Standard Error 0.211 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48 | 0.02 points on a scale | Standard Error 0.212 |
Secondary
Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48
The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.
Time frame: Baseline and Month 48
Population: Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48 | 0.94 points on a scale | Standard Error 0.123 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48 | -0.37 points on a scale | Standard Error 0.123 |
Secondary
Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48
The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.
Time frame: Baseline and Month 48
Population: Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48 | -0.82 points on a scale | Standard Error 0.064 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48 | -1.5 points on a scale | Standard Error 0.065 |
Secondary
Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48
Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).
Time frame: Baseline, Month 24, and Month 48
Population: Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48 | Month 24, n=3192, 3116 | 13.0 percent change | Standard Error 0.65 |
| Placebo | Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48 | Month 48, n=3289, 3194 | 19.7 percent change | Standard Error 0.77 |
| Dutasteride 0.5 mg | Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48 | Month 24, n=3192, 3116 | -17.4 percent change | Standard Error 0.48 |
| Dutasteride 0.5 mg | Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48 | Month 48, n=3289, 3194 | -17.5 percent change | Standard Error 0.54 |
Secondary
Mean Change From Baseline in Testosterone at Month 48
Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.
Time frame: Baseline and Month 48
Population: Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Testosterone at Month 48 | -0.1 percent change | Standard Deviation 36.95 |
| Dutasteride 0.5 mg | Mean Change From Baseline in Testosterone at Month 48 | 20.0 percent change | Standard Deviation 44.05 |
p-value: <0.00195% CI: [17.3, 20.4]general linear model, t-test
Secondary
Number of Cancer-positive Cores
The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.
Time frame: Baseline to Year 4
Population: Prostate Cancer Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cancer-positive Cores | 1.9 number of cores | Standard Deviation 1.31 |
| Dutasteride 0.5 mg | Number of Cancer-positive Cores | 1.8 number of cores | Standard Deviation 1.33 |
Secondary
Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms
Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.
Time frame: Years 1-2, Overall (Years 1-4)
Population: Efficacy Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms | Overall | 770 participants |
| Placebo | Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms | Years 1-2 | 425 participants |
| Dutasteride 0.5 mg | Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms | Overall | 515 participants |
| Dutasteride 0.5 mg | Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms | Years 1-2 | 317 participants |
Secondary
Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment
The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).
Time frame: Baseline to Year 4
Population: Efficacy Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment | Any intervention | 438 participants |
| Placebo | Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment | Any surgical intervention | 304 participants |
| Placebo | Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment | Any non-surgical intervention | 172 participants |
| Dutasteride 0.5 mg | Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment | Any intervention | 300 participants |
| Dutasteride 0.5 mg | Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment | Any surgical intervention | 221 participants |
| Dutasteride 0.5 mg | Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment | Any non-surgical intervention | 95 participants |
Secondary
Number of Participants With at Least One Event of Acute Urinary Retention (AUR)
A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.
Time frame: Years 1-2 and Overall (Years 1-4)
Population: Efficacy Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With at Least One Event of Acute Urinary Retention (AUR) | Years 1-2 | 150 participants |
| Placebo | Number of Participants With at Least One Event of Acute Urinary Retention (AUR) | Overall | 272 participants |
| Dutasteride 0.5 mg | Number of Participants With at Least One Event of Acute Urinary Retention (AUR) | Years 1-2 | 39 participants |
| Dutasteride 0.5 mg | Number of Participants With at Least One Event of Acute Urinary Retention (AUR) | Overall | 63 participants |
Secondary
Number of Participants With at Least One Urinary Tract Infection (UTI)
A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Population: Efficacy Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With at Least One Urinary Tract Infection (UTI) | Years 3-4, n=3363, 3318 | 164 participants |
| Placebo | Number of Participants With at Least One Urinary Tract Infection (UTI) | Years 1-2, n=4073, 4049 | 196 participants |
| Placebo | Number of Participants With at Least One Urinary Tract Infection (UTI) | Overall, n=4073, 4049 | 360 participants |
| Dutasteride 0.5 mg | Number of Participants With at Least One Urinary Tract Infection (UTI) | Years 3-4, n=3363, 3318 | 83 participants |
| Dutasteride 0.5 mg | Number of Participants With at Least One Urinary Tract Infection (UTI) | Years 1-2, n=4073, 4049 | 131 participants |
| Dutasteride 0.5 mg | Number of Participants With at Least One Urinary Tract Infection (UTI) | Overall, n=4073, 4049 | 214 participants |
Secondary
Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy
The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category (HGPIN or prostate cancer diagnosis) and again in the last category (HGPIN, ASAP, or prostate cancer diagnosis).
Time frame: Baseline to Year 4
Population: Biopsied Population: the number analyzed is the total number in the population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN and no prostate cancer | 268 participants |
| Placebo | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN or ASAP | 675 participants |
| Placebo | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN or prostate cancer diagnosis | 1126 participants |
| Placebo | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN or ASAP and no prostate cancer | 373 participants |
| Placebo | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN and no ASAP and no prostate cancer | 206 participants |
| Placebo | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN, ASAP, or prostate cancer diagnosis | 1231 participants |
| Dutasteride 0.5 mg | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN, ASAP, or prostate cancer diagnosis | 907 participants |
| Dutasteride 0.5 mg | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN or prostate cancer diagnosis | 810 participants |
| Dutasteride 0.5 mg | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN and no prostate cancer | 151 participants |
| Dutasteride 0.5 mg | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN and no ASAP and no prostate cancer | 121 participants |
| Dutasteride 0.5 mg | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN or ASAP | 409 participants |
| Dutasteride 0.5 mg | Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy | HGPIN or ASAP and no prostate cancer | 248 participants |
Secondary
Number of Participants With Post-biopsy Macroscopic Hematospermia
Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.
Time frame: Baseline through Year 4
Population: Efficacy Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Post-biopsy Macroscopic Hematospermia | 78 participants |
| Dutasteride 0.5 mg | Number of Participants With Post-biopsy Macroscopic Hematospermia | 53 participants |
Secondary
Number of Participants With Post-biopsy Macroscopic Hematuria
Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.
Time frame: Baseline to Year 4
Population: Efficacy Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Post-biopsy Macroscopic Hematuria | 168 participants |
| Dutasteride 0.5 mg | Number of Participants With Post-biopsy Macroscopic Hematuria | 127 participants |
Secondary
Number of Participants With the Indicated Gleason Score at Diagnosis
Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.
Time frame: Baseline to Year 4
Population: Biopsied Population: all randomized participants with a negative entry biopsy who received at least 1 dose of study treatment and who had at least 1 biopsy reviewed by the central pathology lab. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Gleason Score at Diagnosis | Between 2 and 6 | 617 participants |
| Placebo | Number of Participants With the Indicated Gleason Score at Diagnosis | Between 7 and 10 | 233 participants |
| Placebo | Number of Participants With the Indicated Gleason Score at Diagnosis | Between 8 and 10 | 19 participants |
| Dutasteride 0.5 mg | Number of Participants With the Indicated Gleason Score at Diagnosis | Between 2 and 6 | 437 participants |
| Dutasteride 0.5 mg | Number of Participants With the Indicated Gleason Score at Diagnosis | Between 7 and 10 | 220 participants |
| Dutasteride 0.5 mg | Number of Participants With the Indicated Gleason Score at Diagnosis | Between 8 and 10 | 29 participants |
Secondary
Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48
Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.
Time frame: Month 48
Population: Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48 | <0.555 nanomoles/Liter | 493 participants |
| Placebo | Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48 | <level of detection | 42 participants |
| Dutasteride 0.5 mg | Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48 | <0.555 nanomoles/Liter | 3414 participants |
| Dutasteride 0.5 mg | Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48 | <level of detection | 2210 participants |
Secondary
Overall Survival
Overall survival is assessed as the number of deaths reported throughout the study.
Time frame: From time informed consent is signed to 4-month Safety Follow-Up period
Population: Efficacy Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Overall Survival | Years 1-2 | 29 number of deaths |
| Placebo | Overall Survival | Overall | 77 number of deaths |
| Dutasteride 0.5 mg | Overall Survival | Years 1-2 | 32 number of deaths |
| Dutasteride 0.5 mg | Overall Survival | Overall | 70 number of deaths |
Secondary
Percentage of Core Involved at Diagnosis
The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.
Time frame: Baseline to Year 4
Population: Prostate Cancer Population: all participants in the Efficacy Population who received a post-baseline diagnosis of prostate cancer by the central pathology laboratory. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage of Core Involved at Diagnosis | 13.4 percentage of core | Standard Deviation 14.84 |
| Dutasteride 0.5 mg | Percentage of Core Involved at Diagnosis | 12.2 percentage of core | Standard Deviation 13 |
Secondary
Treatment Alteration Score
The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.
Time frame: Baseline to Year 4
Population: Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Treatment Alteration Score | Nuclear, n=3357, 3256 | 0.008 points on a scale | Standard Deviation 0.1116 |
| Placebo | Treatment Alteration Score | Architectural, n=3357, 3258 | 0.009 points on a scale | Standard Deviation 0.1289 |
| Placebo | Treatment Alteration Score | Total, n=3357, 3256 | 0.017 points on a scale | Standard Deviation 0.2336 |
| Dutasteride 0.5 mg | Treatment Alteration Score | Nuclear, n=3357, 3256 | 0.019 points on a scale | Standard Deviation 0.1734 |
| Dutasteride 0.5 mg | Treatment Alteration Score | Architectural, n=3357, 3258 | 0.023 points on a scale | Standard Deviation 0.2112 |
| Dutasteride 0.5 mg | Treatment Alteration Score | Total, n=3357, 3256 | 0.041 points on a scale | Standard Deviation 0.3737 |
Secondary
Volume of HGPIN at Biopsy
The amount of prostate biopsy tissue with HGPIN was measured.
Time frame: Baseline to Year 4
Population: Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Volume of HGPIN at Biopsy | 0.1105 cc*10^-3 (microliter) | Standard Deviation 0.52753 |
| Dutasteride 0.5 mg | Volume of HGPIN at Biopsy | 0.0446 cc*10^-3 (microliter) | Standard Deviation 0.2771 |