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

Sponsor:	Roswell Park Cancer Institute
Information provided by (Responsible Party):	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00736645

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: selenomethionine Drug: finasteride Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Finasteride Selenomethionine Selenium

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Quantities of androgen receptor, prostate-specific antigen, kallikrein 2, and NKX 3.1 message expression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Apoptosis as assessed by TUNEL assay, immunohistochemistry, and ELISA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Relationship between Prx1 level and response to treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	164
Study Start Date:	August 2008
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.	Dietary Supplement: selenomethionine Given orally Drug: finasteride Given orally
Experimental: Arm II Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.	Drug: finasteride Given orally Other: placebo Given orally
Experimental: Arm III Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.	Dietary Supplement: selenomethionine Given orally Other: placebo Given orally
Placebo Comparator: Arm IV Patients receive two oral placebos once daily for 4-5 weeks.	Other: placebo Given orally

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

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 4-5 weeks prior to prostatectomy/brachytherapy

PRIOR CONCURRENT THERAPY:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736645

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: AskRPCI 877-275-7724 AskRPCI@RoswellPark.org

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Principal Investigator:

James L. Mohler, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00736645 History of Changes
Other Study ID Numbers:	CDR0000611962, RPCI I 104607
Study First Received:	August 15, 2008
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Selenium
Finasteride
Trace Elements

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
5-alpha Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012