Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00985738 |
Recruitment Status :
Terminated
(Low recruitment)
First Posted : September 28, 2009
Results First Posted : April 18, 2016
Last Update Posted : May 17, 2016
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Drug: Dutasteride Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Placebo-Controlled Double-Blind Clinical Trial to Assess the Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Dutasteride
The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.
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Drug: Dutasteride
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.
Other Name: Avodart |
Placebo Comparator: Placebo
The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.
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Other: Placebo
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. |
- 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. [ Time Frame: 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.

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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985738
United States, Colorado | |
University of Colorado Hospital | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Al Barqawi, MD | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT00985738 |
Other Study ID Numbers: |
09-0247.cc |
First Posted: | September 28, 2009 Key Record Dates |
Results First Posted: | April 18, 2016 |
Last Update Posted: | May 17, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Prostate Cancer Early Stage Prostate Cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Dutasteride |
5-alpha Reductase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |