Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: M.D. Anderson Cancer Center
• Treatments: Finasteride

Criteria

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)