Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Finasteride in Treating Patients Undergoing Surgery for Stage II Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	Adult	NCI	MDA-03-1-03 MDA-2006-0614, MDA03-1-03, NCT00438464

Objectives

Primary

1. 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

1. Compare the frequency with which grade 3 and grade 4 tumors occur in these patients.
2. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients.
3. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo.
4. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.
5. Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

Entry Criteria

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

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)

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

Expected Enrollment

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

Outcomes

Frequency of discriminating molecular marker expression in Gleason grade 3 cores

Frequency of grade 3 and grade 4 tumor occurrence
Frequency of discriminating molecular signature expression in tissue microarray cores segregated by Gleason score at prostatectomy

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Jeri Kim, MD, Protocol chair		Ph: 713-563-7237; 800-392-1611

U.S.A.
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	San Antonio
	University of Texas Health Science Center at San Antonio
		Joseph Basler, MD, PhD	Ph:  210-567-5640
			Email: basler@uthscsa.edu

Registry Information
Official Title		A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients with Clinically Organ-Confined Prostate Cancer
Trial Start Date		2007-02-15
Trial Completion Date		2011-07-12 (estimated)
Registered in ClinicalTrials.gov		NCT00438464
Date Submitted to PDQ		2007-01-16
Information Last Verified		2008-11-30
NCI Grant/Contract Number		CN35159, CA16672

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