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

Prostate Cancer Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled Clinical Trial of L-SeMet Supplementation and Finasteride Treatment of Patients With Prostate Cancer Prior to Robotic Prostatectomy/Brachytherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736645
• Other study ID #: CDR0000611962
• Secondary ID: RPCI I 104607
• Status: Completed
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven adenocarcinoma of the prostate

• Diagnosed by sextant or greater biopsy

• Clinical stage < T3 (stage I or II) disease

• Prostate-specific antigen < 20.0 ng/mL

• Gleason score < 8

• Scheduled to undergo prostatectomy or brachytherapy

PATIENT CHARACTERISTICS:

• Life expectancy > 5 years

• No other prior malignancy (excluding nonmelanoma skin cancer) in the past 5 years

• Willing and able to take finasteride, selenomethionine, and/or placebo for 3-5 weeks prior to prostatectomy/brachytherapy

PRIOR CONCURRENT THERAPY:

• More than 1 year since prior finasteride, dutasteride, Sereona repens (saw palmetto), or any other 5-a reductase inhibitor

• No prior hormonal therapy or radiotherapy

• More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modification or exercise)

• No concurrent selenium dietary supplement at doses > 200 mg/day, including multivitamin supplements

• At least 30 days since > 200mg/day of prior selenium dietary supplement

• No other concurrent hormonal therapy, including 5-a reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• selenomethionine
Given orally

Drug:
• finasteride
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Selenium and Finasteride and Their Combination on PSA Level	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.	1 year
Secondary	Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction	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.	1 year