Clinical trial · Interventional
Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.
A Randomized, Phase IIB, Double Blind, Placebo Controlled, Multicenter, Pre-surgical, Window-of-opportunity Trial of Finasteride Vs. Low-dose Flutamide Vs. Placebo in Prostate Cancer (2F Trial)
- 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)
Pre-surgical, window-of-opportunity trials provide a suitable model to assess the activity of preventive interventions in a cost-effective manner using tissue biomarkers as surrogate endpoints. Finasteride has been shown to reduce prostate cancer development in a large phase III trial, and flutamide has a well-known anticancer effect in advanced prostate cancer at the dose of 750 mg/day.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Intraepithelial Neoplasia | Prostatic Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Finasteride | Drug | — | UNRESOLVED |
| Flutamide | Drug | Flutamide | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Flutamide
- description
- 1 tablet 250 mg daily until the day before surgery
- interventionNames
- Drug: Flutamide
- type
- EXPERIMENTAL
- label
- Finasteride
- description
- 1 tablet 5 mg daily until the day before surgery
- interventionNames
- Drug: Finasteride
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 1 tablet daily until the day before surgery
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \> 18 years * Patients with a biopsy proven, clinically intracapsular PCa who are candidates to radical retropubic prostatectomy * ECOG performance status ≤ 2 * Satisfactory hematological and biochemical functions: * Platelets ≥100 x 10\^9/L * AST and ALT in the normal range * Able to understand and sign an informed consent Exclusion Criteria: * Previous hormone treatment during the 8 weeks before enrollment * Neurologic and psychiatric diseases precluding patient participation in the study * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with the study procedures.
References
Publications (0)
Data not yet available