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A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Adenocarcinoma of the Prostate, Stage II Prostate Cancer

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Trial Information

A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Molecular marker expression based on tissue microarray (TMA) derived from the dominant tumor focus

Outcome Description:

Data analysis will use a mixed-effects regression model, an approach appropriate for repeated measures (of continuous variables) from single participants.

Outcome Time Frame:

At time of prostatectomy

Safety Issue:

No

Principal Investigator

Jeri Kim

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

NCI-2009-00856

NCT ID:

NCT00438464

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Stage II Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location
M D Anderson Cancer Center Houston, Texas  77030
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195