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

NCT00736645 | Completed Phase 2 Results DMC

• 2 other identifiers: CDR0000611962RPCI I 104607
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction

  1 year

Study Arms (4)

Arm I

EXPERIMENTAL

Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.

Dietary Supplement: selenomethionine; Drug: finasteride

Arm II

EXPERIMENTAL

Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.

Drug: finasteride; Other: placebo

Arm III

EXPERIMENTAL

Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.

Dietary Supplement: selenomethionine; Other: placebo

Arm IV

PLACEBO COMPARATOR

Patients receive two oral placebos once daily for 4-5 weeks.

Other: placebo

Interventions

selenomethionine DIETARY_SUPPLEMENT

Given orally

Arm I; Arm III

finasteride DRUG

Given orally

Arm I; Arm II

placebo OTHER

Given orally

Arm II; Arm III; Arm IV

Eligibility Criteria

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

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-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)

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

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Selenomethionine; Finasteride

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; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

Adrienne.Groman@RoswellPark.org

716-845-2300

Study Officials

• James L. Mohler, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 2, 2023
• Results First Posted: November 28, 2017

Record last verified: 2023-09

Locations

US (1)