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Study Summary
No. 2006-0614:.......Prostate......Jeri Kim......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:		2006-0614
Study Title:A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients with Clinically Organ-Confined Prostate Cancer.
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Physician New Patient Referral
Name:Jeri KimPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Genitourinary Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Patient will return 24 hours prior to surgery for blood testing and collection
of pill diaries.
Treatment
Agents:		FinasterideHome Care:All study medications are taken orally by the patient at home.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
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:
          a. 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
          b. 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
          c. 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
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:08/16/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:200
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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%]

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.
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Links
Registration Number: NCT00438464
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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