NCT00438464

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores, adjusted for Gleason score (GS) at prostatectomy, in patients with stage II prostate cancer treated with neoadjuvant finasteride vs placebo. SECONDARY OBJECTIVES: I. Compare the frequency with which grade 3 and grade 4 tumors occur in these patients. II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients. III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo. IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo. V. Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study site, Gleason score (6 vs 7), and type of prostatectomy (open vs robotic/laparoscopic). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy. Arm II: Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy. Tumor tissue obtained at prostatectomy is used to make tissue microarrays and is analyzed by immunohistochemistry for molecular marker expression studies. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Adenocarcinoma of the Prostate
• Stage II Prostate Cancer

Interventions

Type	Name	Description
DRUG	Finasteride	Given PO
OTHER	Placebo	Given PO
PROCEDURE	Prostatectomy	Undergo prostatectomy
OTHER	Laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2007-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2007-02-22
• Last updated: 2016-03-09
• Results posted: 2016-03-09

Locations

8 sites across 1 country: United States