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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage II Prostate Cancer; Adenocarcinoma of the Prostate

Treatments: Drug: Finasteride; Other: Placebo; Other: Laboratory biomarker analysis; Procedure: Prostatectomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00438464

P30CA016672 (U.S. NIH Grant/Contract)

CDR0000653463

NCI-2009-00856 (Registry Identifier)

2006-0614 (Other Identifier)

N01CN35159 (U.S. NIH Grant/Contract)

MDA03-1-03 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

204 participants in 2 patient groups, including a placebo group

Arm I (Finasteride)

Experimental group

Description:

Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.

Treatment:

Procedure: Prostatectomy

Other: Laboratory biomarker analysis

Drug: Finasteride

Arm II (Placebo)

Placebo Comparator group

Description:

Placebo once daily for 4-6 weeks, then undergo prostatectomy.

Treatment:

Other: Laboratory biomarker analysis

Other: Placebo