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

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ClinicalTrials.gov Identifier: NCT00736645
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: selenomethionine Drug: finasteride Other: placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Effects of Selenium and Finasteride and Their Combination on PSA Level [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736645


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: James L. Mohler, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00736645     History of Changes
Other Study ID Numbers: CDR0000611962
RPCI I 104607 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: August 18, 2008    Key Record Dates
Results First Posted: November 28, 2017
Last Update Posted: November 28, 2017
Last Verified: October 2017

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
Finasteride
Selenium
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents
Antioxidants
Protective Agents
Trace Elements
Micronutrients
Growth Substances