Text Size

Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00438464
First received: February 20, 2007
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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 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


Condition Intervention Phase
Adenocarcinoma of the Prostate
Stage II Prostate Cancer
 Drug: finasteride
Other: placebo
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Finasteride
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Molecular marker expression based on tissue microarray (TMA) derived from the dominant tumor focus [ Time Frame: At time of prostatectomy ] [ Designated as safety issue: No ]
    Data analysis will use a mixed-effects regression model, an approach appropriate for repeated measures (of continuous variables) from single participants.


Secondary Outcome Measures:
  • Molecular marker expression compared between tumor foci [ Time Frame: At time of prostatectomy ] [ Designated as safety issue: No ]
    The use of all data will be maximized by performing matched and unpaired or unmatched data analysis.

  • Frequencies with which two GGs appear in tumor foci [ Time Frame: At time of prostatectomy ] [ Designated as safety issue: No ]
    The use of all data will be maximized by performing matched and unpaired or unmatched data analysis.


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)
Patients receive finasteride PO QD for 4-6 weeks, and then undergo prostatectomy.
 Drug: finasteride
Given PO
Other Names:
  • Finastid
  • MK 906
  • Proscar
  • Prostide
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy.
 Other: placebo
Given PO
Other Name: PLCB
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Other: laboratory biomarker analysis
Correlative studies

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 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.

  Eligibility

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

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
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438464

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeri Kim M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00438464     History of Changes
Other Study ID Numbers: NCI-2009-00856, 2006-0614, N01CN35159
Study First Received: February 20, 2007
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
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 23, 2013