Selenomethionine in Treating Patients Undergoing Surgery or Internal Radiation Therapy for Stage I or Stage II Prostate Cancer

NCT00736164 | Withdrawn Phase 2

• 3 other identifiers: CDR0000611981P30CA016056RPCI-I-104307
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Selenomethionine may slow the growth of prostate cancer. Giving selenomethionine before surgery or internal radiation therapy may be an effective treatment for prostate cancer. PURPOSE: This randomized phase II trial is studying how well selenomethionine works in treating patients undergoing surgery or internal radiation therapy for stage I or stage II prostate cancer.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Quantity of androgen receptor message expression

Secondary Outcomes (3)

• Expression of prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24

• Expression of haptic nuclear factor 3-alpha

• Variation in thiol methyltransferase phenotype

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral selenomethionine once daily for 8-9 weeks.

Dietary Supplement: selenomethionine

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo once daily for 8-9 weeks.

Other: placebo

Interventions

selenomethionine DIETARY_SUPPLEMENT

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Diagnosed by sextant or greater biopsy * Clinical stage T1a-T2c disease * Gleason score \< 8 * Prostate-specific antigen \< 20.0 ng/mL * Scheduled to undergo prostatectomy or brachytherapy PATIENT CHARACTERISTICS: * Life expectancy \> 5 years * No other prior malignancy except nonmelanoma skin cancer * Willing to take selenomethionine or placebo for 8-9 weeks immediately prior to undergoing prostatectomy or brachytherapy PRIOR CONCURRENT THERAPY: * 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 lifestyle intervention (e.g., dietary modification or exercise) * No concurrent dietary supplementation with selenium at doses \> 60 mcg/day, including multivitamin supplements * No concurrent hormonal therapy, including 5-alpha 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Selenomethionine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organoselenium Compounds; Organic Chemicals; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• James L. Mohler, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2012
• Last Updated: February 6, 2012

Record last verified: 2012-02