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

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	National Cancer Institute (NCI) The Cleveland Clinic The University of Texas Health Science Center at San Antonio South Texas Veterans Health Care System Cancer Therapy and Research Center, Texas University of Texas Southwestern Medical Center
Information provided by (Responsible Party):	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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

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 ]
Percentage of tumor cells exhibiting detectable staining. Molecular marker expression based on tissue microarray (TMA) constructed from paraffin-embedded tissue samples after therapy.

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: 6 weeks (at time of prostatectomy) ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2007
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

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

Detailed Description:

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:

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
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
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

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 versus 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 Prostate-specific antigen (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 MD Anderson Cancer Center.
Participant has a performance status of < 2 (Eastern Cooperative Oncology Group (ECOG) scale) [Karnofsky >/= .70%]
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
Cleveland, Ohio, United States, 44195
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University Hospital
San Antonio, Texas, United States, 78229
South Texas Veterans Health Care System/Audie Murphy Memorial Hospital Division
San Antonio, Texas, United States, 78229-4404
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

The Cleveland Clinic

The University of Texas Health Science Center at San Antonio

South Texas Veterans Health Care System

Cancer Therapy and Research Center, Texas

University of Texas Southwestern Medical Center

Investigators

Study Chair:	Jeri Kim, MD	M.D. Anderson Cancer Center
Study Director:	Powel Brown, MD, PhD	UT MDACC Phase I/II Prevention Consortium

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
ClinicalTrials.gov Identifier:	NCT00438464 History of Changes
Other Study ID Numbers:	2006-0614, MDA-03-1-03, MDA-2006-0614, CDR0000531778
Study First Received:	February 20, 2007
Last Updated:	April 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

stage II prostate cancer
adenocarcinoma of the prostate
Finasteride

Proscar
Surgery
prostatectomy

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012