Clinical trial · Interventional
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
- 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)
Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization. There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
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 |
| prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- dutasteride
- description
- treatment group
- interventionNames
- Drug: dutasteride
- Procedure: prostate biopsy
- type
- ACTIVE_COMPARATOR
- label
- watchful waiting strategy
- interventionNames
- Procedure: prostate biopsy
Primary outcomes (1)
- measure
- rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
- timeFrame
- 6, 12, 24, and 36 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age - 40-80 years 2. HPIN on prostate biopsy specimens 3. PSA below 20ng/ml 4. No hormone therapy or radiation in pelvic region 5. No previous treatment with 5alfa reductase inhibitors 6. Signed Subject Information and Informed Subject Consent Form. Exclusion Criteria: 1\. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
References
Publications (0)
Data not yet available