Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
NCT ID: NCT00438464
Last Updated: 2016-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2007-02-28
2012-04-30
Brief Summary
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Detailed Description
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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 prostate cancer treated with neoadjuvant finasteride vs placebo.
SECONDARY OBJECTIVES:
I. Compare the frequency with which grade 3 and grade 4 tumors occur in these patients.
II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients.
III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo.
IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.
V. 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 finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy.
Arm II: Patients receive placebo PO QD for 4-6 weeks, and 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 up for 30 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (Finasteride)
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Finasteride
Given PO
Prostatectomy
Undergo prostatectomy
Laboratory biomarker analysis
Correlative studies
Arm II (Placebo)
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Placebo
Given PO
Laboratory biomarker analysis
Correlative studies
Interventions
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Finasteride
Given PO
Placebo
Given PO
Prostatectomy
Undergo prostatectomy
Laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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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)
18 Years
MALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jeri Kim
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
University Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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NCI-2009-00856
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000653463
Identifier Type: -
Identifier Source: secondary_id
2006-0614
Identifier Type: OTHER
Identifier Source: secondary_id
MDA03-1-03
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00856
Identifier Type: -
Identifier Source: org_study_id
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