CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 204 enrolled
Drug / intervention
Finasteride +3 moredrug
Likely dose
Finasteride oral dose not specified in published trial recordAI-extracted
Key inclusion· 6
  • Histologically confirmed prostate adenocarcinoma
  • Clinical stage T1c or T2 (stage II)
  • Gleason score 6 or 7 on initial biopsy
  • PSA <10 ng/mL within past 3 months
Key exclusion· 7
  • Prior hormonal agents (including dutasteride or finasteride) within 6 months
  • Prior chemotherapy within 6 months
  • Prior radiotherapy for the primary tumor
  • Concurrent antiandrogen therapy, dutasteride, finasteride, or dehydroepiandrosterone/phytoestrogen supplements

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00438464
NCT00438464Phase 2Completed

A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Feb 22, 2007·Updated Mar 9, 2016

In Brief

A Phase 2 clinical trial evaluating Finasteride, Placebo, and 2 other interventions for Adenocarcinoma of the Prostate and Stage II Prostate Cancer. Completed, enrolled 204 participants across 8 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2007
Enrollment StartFeb 1, 2007
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 19.4 years ago

Interventions

Finasteridedrug

Given PO

Placeboother

Given PO

Prostatectomyprocedure

Undergo prostatectomy

Laboratory biomarker analysisother

Correlative studies