Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	RPCI-I-104607 I 104607, NCT00736645

Objectives

Primary

1. 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

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

Tertiary

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

Entry Criteria

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

Prior/Concurrent Therapy:

• More than 1 year since prior finasteride, dutasteride, Sereona repens (saw palmetto), or any other 5-α 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 > 60 mg/day, including multivitamin supplements
• No other concurrent hormonal therapy, including 5-α 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)

Patient Characteristics:

• Life expectancy > 5 years
• No other prior malignancy except nonmelanoma skin cancer
• Willing and able to take finasteride, selenomethionine, and/or placebo for 4-5 weeks prior to prostatectomy/brachytherapy

Expected Enrollment

Outcomes

Quantities of androgen receptor, prostate-specific antigen, kallikrein 2, and NKX 3.1 message expression

Apoptosis as assessed by TUNEL assay, immunohistochemistry, and ELISA
Relationship between Prx1 level and response to treatment

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

James Mohler, MD, Principal investigator		Ph: 716-845-3389; 800-685-6825

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		James Mohler, MD	Ph:  716-845-8433

Registry Information
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
Trial Start Date		2008-08-06
Trial Completion Date		2013-05-15 (estimated)
Registered in ClinicalTrials.gov		NCT00736645
Date Submitted to PDQ		2008-08-08
Information Last Verified		2009-11-05
NCI Grant/Contract Number		CA16056

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