Clinical trial · Interventional
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer
- 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)
This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Finasteride | Drug | — | UNRESOLVED |
| Laboratory biomarker analysis | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Finasteride)
- description
- Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
- interventionNames
- Drug: Finasteride
- Procedure: Prostatectomy
- Other: Laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II (Placebo)
- description
- Placebo once daily for 4-6 weeks, then undergo prostatectomy.
- interventionNames
- Other: Placebo
- Other: Laboratory biomarker analysis
Primary outcomes (4)
- measure
- Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1c or T2 (stage II) * Gleason score of 6 or 7 on initial biopsy * Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months * Candidate for and scheduled to undergo prostatectomy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 70-100% * Fertile patients must use effective contraception * No active malignancy at any other site * No history of allergic reactions attributed to compounds of similar chemical or biological composition to finasteride * No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia * No psychiatric illness or social situation that would preclude study compliance * More than 6 months since prior hormonal agents, including dutasteride or finasteride * More than 6 months since prior chemotherapy * More than 1 month since prior participation in another investigational study * No prior radiotherapy for the primary tumor * No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, dutasteride, or other finasteride * No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg to 325 mg)
References
Publications (0)
Data not yet available