Clinical trial · Interventional
Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer. PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.
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
- Arm I
- description
- Patients receive oral dutasteride once daily on days 1-14.
- interventionNames
- Drug: dutasteride
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo once daily on days 1-14.
- interventionNames
- Other: placebo
Primary outcomes (3)
- measure
- Efficacy of short-term dutasteride in improving prostate cancer detection
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Suspected prostate cancer due to 1 of the following criteria: * Prior abnormal digital rectal exam * Elevated prostate-specific antigen (PSA) ≥ 2.6 ng/mL within the past 90 days * PSA velocity \> 0.75 ng/mL/year * Must be planning to undergo a transrectal ultrasound with biopsy PATIENT CHARACTERISTICS: * Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy * Must not be clinically unstable, severely ill, or moribund PRIOR CONCURRENT THERAPY: * More than 30 days since prior biopsy of the prostate * More than 1 week since prior acetylsalicylic acid or blood thinner * More than 30 days since prior participation in a clinical trial involving an investigational drug * No prior therapy for prostate cancer * No other concurrent 5-alpha reductase inhibitor
References
Publications (1)
- DERIVEDHalpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19. PMID 22998915