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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

James L. Mohler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000611962

NCT ID:

NCT00736645

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263