Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Dietary Supplement: selenomethionine
Other: placebo
Drug: finasteride

Registration Number: NCT00736645

Lead Sponsor: Roswell Park Cancer Institute

Brief Summary: RATIONALE: Selenomethionine may slow the growth of prostate cancer. Testosterone can cause the growth of prostate cancer cells. Finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving selenomethionine together with finasteride before surgery or radiation therapy may be an effective treatment for prostate cancer.

PURPOSE: This randomized phase II trial is studying how well selenomethionine and finasteride work when given before surgery or radiation therapy in treating patients with stage I or stage II prostate cancer.

Detailed Description: OBJECTIVES:

Primary

* To investigate the effects of selenomethionine and/or finasteride on key androgen receptor signaling biomarkers (prostate-specific antigen, kallikrein 2, and NKX3.1) in prostate tissue samples from patients with stage I or II prostate cancer.

Secondary

* To analyze the effects of selenomethionine and/or finasteride on apoptosis induction in benign prostate tissue samples from these patients.

Tertiary

* To determine whether responsiveness to selenomethionine and/or finasteride is related to the level of Prx1 in prostate cancer cells.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy.

* Arm II: Patients receive oral placebo and oral finasteride once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy.

* Arm III: Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy.

* Arm IV: Patients receive two oral placebos once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy.

Blood samples are collected at baseline and on the day of prostatectomy or brachytherapy. Samples are analyzed for testosterone and 5-α-dihydrotestosterone levels by capillary gas chromatography-mass spectrometry; genetic polymorphisms in the type 2 5-α reductase gene by PCR and sequencing analyses; and selenium levels by atomic absorption spectrophotometry. Additional blood samples will be stored for future analysis of alpha and gamma tocopherol, lycopene, and other vitamin levels. Toenail samples are also collected to provide an indicator of long-term selenium status. Prostate tissue samples are collected during and after prostatectomy or prior to brachytherapy. Samples are analyzed for expression of biomarkers (e.g., prostate-specific antigen, kallikrein 2, and NKX 3.1) by quantitative RT-PCR and apoptosis by TUNEL assay, immunohistochemistry, and ELISA.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	selenomethionine	Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Arm II	placebo	Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Arm III	selenomethionine	Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Arm III	placebo	Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Arm IV	placebo	Patients receive two oral placebos once daily for 4-5 weeks.
Arm I	finasteride	Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Arm II	finasteride	Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.

Primary Outcome Measures

Name	Time	Method
Effects of Selenium and Finasteride and Their Combination on PSA Level	1 year	Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.

Secondary Outcome Measures

Name	Time	Method
Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction	1 year	Compare cleaved caspase 3 values with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of cleaved caspase 3 values of Arm A, Arm B, Arm D with Arm C.