Finasteride in Treating Patients Undergoing Surgery for Stage II Prostate Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00438464

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Finasteride Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Surgery

Drug Information available for: Finasteride

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Frequency of discriminating molecular marker expression in Gleason grade 3 cores [ Time Frame: After 4-6 week dosing cycle + prostate removal surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of grade 3 and grade 4 tumor occurrence [ Time Frame: After 4-6 week dosing cycle + prostate removal surgery ] [ Designated as safety issue: No ]
Frequency of discriminating molecular signature expression in tissue microarray cores segregated by Gleason score at prostatectomy [ Time Frame: At time of prostatectomy ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2007
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Finasteride: Experimental Oral 5 mg once daily for 4-6 weeks.	Drug: Finasteride 5 mg orally once daily for 4-6 weeks
Arm II: Placebo: Placebo Comparator Oral placebo once daily for 4-6 weeks.	Other: Placebo Oral placebo once daily for 4-6 weeks.

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
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.
Participant has a performance status of < 2 (ECOG scale) [Karnofsky >/= 70 percent]
Participant agrees to have tissue blocks of the prostatectomy specimen after prostatectomy used for molecular marker studies.
Participant is a candidate for and scheduled to undergo prostatectomy.
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.
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.
Men of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

Active malignancy at any other site.
Prior radiation therapy for treatment of the primary tumor.
Participation in another investigational study within one month before enrollment.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to finasteride.
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.
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).
Use of all hormonal agents, including saw palmetto, dutasteride and finasteride within 6 months of study entry.
Use of chemotherapy within 6 months of study entry.
Women are excluded from the study because they are not at risk for prostate cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438464

Locations

United States, Ohio
Cleveland Clinic Taussig Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
United States, Texas
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: UT MDACC 713-792-3245
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Recruiting
Dallas, Texas, United States, 75390
Contact: 214-648-7097 Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Joseph W. Basler, MD, PhD 210-567-5640 basler@uthscsa.edu

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jeri Kim, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M. D. Anderson Cancer Center at University of Texas ( Scott Michael Lippman )
Study ID Numbers:	2006-0614, MDA-03-1-03, MDA-2006-0614, CDR0000531778
Study First Received:	February 20, 2007
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00438464 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Finasteride
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Genital Neoplasms, Male

Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010