NCT01497431

Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants

Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This randomized phase I trial studies the side effects and the best dose of Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium compounds, may prevent prostate cancer from forming.

Detailed description

PRIMARY OBJECTIVES: I. To determine the individual toxicity profiles of Se-methyl-seleno-L-cysteine (methyl selenocysteine; MSC) and selenomethionine (SeMet) administered to cohorts of men daily for twelve weeks, with dose escalation with each successive cohort. SECONDARY OBJECTIVES: I. To measure the pharmacokinetics of selenium, according to form (MSC vs SeMet): MSC and SeMet impacts on plasma, albumin, and urinary concentrations of selenium over 48 hours on dosing days 1 and 84. II. To evaluate the pharmacodynamics of selenium by form (MSC vs SeMet): plasma, albumin, and urinary Selenoprotein P (Sepp1) concentrations and glutathione peroxidase (GPx) activity over 48 hours on dosing days 1 and 84. III. To store plasma and formed elements (red cells plus platelets) for future analysis of methyl selenol and other key selenium species, when those assays become available. OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 3 treatment arms. ARM I: Participants receive Se-methyl-seleno-L-cysteine orally (PO) on days 1-84. ARM II: Participants receive selenomethionine PO on days 1-84. ARM III: Participants receive placebo PO on days 1-84. After completion of study treatment, patients are followed up on day 112.

Conditions

• No Evidence of Disease
• Prostate Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Selenium	Given PO
OTHER	Placebo	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Methylselenocysteine	Given PO

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2011-12-22
• Last updated: 2014-11-26

Locations

3 sites across 1 country: United States