Status:
COMPLETED
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Adenocarcinoma of the Prostate
Stage II Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer ce...
Detailed Description
PRIMARY OBJECTIVES: I. 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 p...
Eligibility Criteria
Inclusion
- Criteria:
- 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
- Eastern Cooperative Oncology Group (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
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00438464
Start Date
February 1 2007
End Date
April 1 2012
Last Update
March 9 2016
Active Locations (8)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
2
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
3
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
4
M D Anderson Cancer Center
Houston, Texas, United States, 77030