Clinical trial · Interventional
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
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
NCT00985738CI-TRIAL-00022223terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment
Summary
Brief summary (as posted)
The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dutasteride | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dutasteride
- description
- The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.
- interventionNames
- Drug: Dutasteride
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.