Prostate Cancer
Conditions
Keywords
Prostate Cancer, Early Stage Prostate Cancer
Brief summary
The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.
Detailed description
This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.
Interventions
DRUGDutasteride
Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy.
OTHERPlacebo
The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.
Sponsors
GlaxoSmithKline
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 40-85 year old males * Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores. * Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management. * Patient will read, understand and sign the informed consent agreement * Patients must have a life expectancy of at least one year. * Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4 * Percentage positive core rate \< 50% based on sextant or extended biopsy technique. * Prostate Volume (PV) \>15 grams. * Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA\> 10 ng.dl before initiation of the study drug
Exclusion criteria
* Any 5α-reductase inhibitors medications within the past 12 months before enrollment. * Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors. * Anticipated blood donation within the next 90 days. * Serum PSA levels of \>20ng/dl. * Clinical evidence of metastatic prostate cancer. * Two documented urinary tract infections in the past year * CHF, MI (within 6 months) or other symptomatic CVS disease * Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric) * Enrollment in other studies for any disease in the past 30 days * Significant urinary incontinence * Diagnosis of cancer that in not considered cured, except BCC of skin * Prior transurethral resection of the prostate with a large tissue defect. * History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology * Previous or concurrent radiotherapy, hormonal therapy or chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume. | 24 Months | The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum. |
Countries
United States
Participant flow
Recruitment details
Between 2009 and 2011, 16 patients were enrolled in the study from the Urologic Oncology clinic and Outpatient Urology clinic.
Pre-assignment details
Subjects who qualified for the study based on the eligibility criteria were randomized to a placebo or treatment arm. After approximately 90 days (± 10 days), patients returned to undergo 3D mapping biopsy as part of their management of prostate cancer and received the tests/procedures outlined in the study calendar.
Participants by arm
| Arm | Count |
|---|---|
| Dutasteride Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy. | 8 |
| Placebo This group received a placebo followed by 3D mapping biopsy. | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study closed prematurely | 8 | 8 |
Baseline characteristics
| Characteristic | Dutasteride | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Continuous | 63.5 Years STANDARD_DEVIATION 6 | 65.8 Years STANDARD_DEVIATION 6.3 | 64.4 Years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.
The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.
Time frame: 24 Months
Population: The study was terminated. Study end points were not reached. No data were collected