Finasteride in Treating Patients Undergoing Surgery for Stage II Prostate Cancer

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.

Primary Objectives:

To compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores of finasteride-treated patients with that in GG 3 cores of placebo-treated patients adjusted for Gleason score (GS) at prostatectomy

Secondary Objectives:

To compare the frequency with which grade 3 and grade 4 tumors occur in the two treatment groups

To determine following treatment with finasteride or placebo the frequency of discriminating molecular signature expression in tissue microarray (TMA) cores segregated by GS at prostatectomy: - In tumors rated GS 6 at prostatectomy: to compare GG 3-appearing areas from finasteride-treated patients with GG 3 areas from placebo-treated patients - In tumors rated GS 7 at prostatectomy: to compare GG 3-appearing areas from finasteride-treated patients with GG 3 areas from placebo-treated patients - In tumors rated GS 7 at prostatectomy: to compare GG 4-appearing areas from finasteride-treated patients with GG 4 areas from placebo-treated patients

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 versus 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
  • 5 mg orally once daily for 4-6 weeks
• Other: Placebo
  • Oral placebo once daily for 4-6 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm I: Finasteride
  • Oral Finasteride 5 mg once daily for 4-6 weeks.
• Placebo Comparator: Arm II: Placebo
  • Oral placebo once daily for 4-6 weeks.

Primary Measures

• Frequency of discriminating molecular marker expression in Gleason grade 3 cores
  • Time Frame: After 4-6 week dosing cycle + prostate removal surgery
    Safety Issue?: No

Secondary Measures

• Frequency of grade 3 and grade 4 tumor occurrence
  • Time Frame: After 4-6 week dosing cycle + prostate removal surgery
    Safety Issue?: No
• Frequency of discriminating molecular signature expression in tissue microarray cores segregated by Gleason score at prostatectomy
  • Time Frame: 6 weeks (at time of prostatectomy)
    Safety Issue?: No

Inclusion Criteria:

• 1. Participant has histologic proof of clinically organ-confined adenocarcinoma of the prostate, clinical stage T1c or T2 with Gleason's grade = 6 (3+3) or 7 (3+4 or 4+3) on initial biopsy, and a Prostate-specific antigen (PSA) value < 10 ng/mL within 3 months of registration.
• 2. Participant agrees not to take dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, saw palmetto, dutasteride or finasteride pill while on study, independent of pill provided by MD Anderson Cancer Center.
• 3. Participant has a performance status of < 2 (Eastern Cooperative Oncology Group (ECOG) scale) [Karnofsky >/= .70%]
• 4. Participant agrees to have tissue blocks of the prostatectomy specimen after prostatectomy used for molecular marker studies.
• 5. Participant is a candidate for and scheduled to undergo prostatectomy.
• 6. Participant agrees to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• 7. Participant signs an informed consent, indicating that he is aware of the investigational nature of this study, in keeping with the policies of the institution.
• 8. Men of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

• 1. Active malignancy at any other site.
• 2. Prior radiation therapy for treatment of the primary tumor.
• 3. Participation in another investigational study within one month before enrollment.
• 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to finasteride.
• 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• 6. Use of anticoagulation agents, except for the use of daily aspirin (81 mg to 325 mg).
• Aspirin will be withheld for 10 days before prostatectomy (the number of days may be modified for 81 mg aspirin or if there is a significant cardiovascular risk).
• 7. Use of all hormonal agents, including saw palmetto, dutasteride and finasteride within 6 months of study entry.
• 8. Use of chemotherapy within 6 months of study entry.
• 9. Women are excluded from the study because they are not at risk for prostate cancer.

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 Investigator: M.D. Anderson Cancer Center Other

Overall Clinical Trial Officials and Contacts

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

Overall Contact: UT MDACC Consortium Department of Clinical Cancer Prevention (713) 792-9594 

Information obtained from ClinicalTrials.gov on February 09, 2012

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

Study ID Number: 2006-0614

ClinicalTrials.gov Identifier: NCT00438464

Health Authority: United States: Food and Drug Administration

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

UT MD Anderson Cancer Center web site