Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	Adult	NCI, Other	2006-0614 MDA-03-1-03, MDA-2006-0614, CDR0000531778, NCT00438464

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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 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 MDACC.

3. Participant has a performance status of < 2 (ECOG scale) [Karnofsky >/= 70 percent]

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Jeri Kim

Study Chair

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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00438464
Information obtained from ClinicalTrials.gov on November 25, 2009

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