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

RATIONALE: 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.

PURPOSE: This randomized phase II trial is studying finasteride to see how well it works compared with a placebo in treating patients undergoing surgery for stage II prostate cancer.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Study Primary Completion Date: July 2011

OBJECTIVES:

Primary - 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 - Compare the frequency with which grade 3 and grade 4 tumors occur in these patients. - Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients. - Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo. - Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo. - 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 oral finasteride once daily. - Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients 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 for 30 days.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: finasteride
  • Oral finasteride once daily
• Other: placebo
  • Oral placebo once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm I
  • Patients receive oral finasteride once daily for 4-6 weeks.
• Placebo Comparator: Arm II
  • Patients receive oral placebo once daily for 4-6 weeks.

Primary Measures

• Frequency of discriminating molecular marker expression in Gleason grade 3 cores
  • Safety Issue?: No

Secondary Measures

• Frequency of grade 3 and grade 4 tumor occurrence
  • Safety Issue?: No
• Frequency of discriminating molecular signature expression in tissue microarray cores segregated by Gleason score at prostatectomy
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: M.D. Anderson Cancer Center

Overall Clinical Trial Officials and Contacts

Jeri Kim, MD Study Chair M.D. Anderson Cancer Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00438464

Study ID Number: CDR0000531778

ClinicalTrials.gov Identifier: NCT00438464

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database