se-methyl-seleno-l-cysteine or selenomethionine in preventing prostate cancer in healthy participants

Conditions: No Evidence of Disease; Prostate Carcinoma

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.

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.

Eligibility criteria:
inclusion criteria: * total body weight between 50 and 115 kg (110 and 250 lbs) * hemoglobin (hgb) \> 12 mg/dl * platelet count \> 100,000/μl * absolute neutrophil count (anc) \> 1000/μl * creatinine =\< institutional upper limit of normal (uln) * serum glutamate pyruvate transaminase (sgpt) and serum glutamic oxaloacetic transaminase (sgot) \< 2.0 x uln * total bilirubin =\< uln (participants with a higher level of bilirubin presumed due to familial metabolism will be considered on an individual basis) * life expectancy greater than 3 years * participants must agree to use adequate contraception (barrier method of birth control; abstinence) from time of screening until study completion (i.e., for at least 2 weeks after last dose of study drug) * ability to understand and the willingness to sign a written informed consent document * agree to refrain from use of selenium (se) supplements (other than the 100 mcg dose common in multivitamins) or se-containing drugs while on study between 30 days before study drug initiation and day 84 exclusion criteria: * not willing to remain at roswell park cancer institute (rpci), and in follow up, as required * presence of medical conditions which, in the opinion of the investigator, would place either the participant or the integrity of the data at risk * serum creatinine \> uln, sgot or sgpt \>= 2.0 x uln, or bilirubin \> uln * treatment with an investigational drug within 30 days prior to the dose of study drug * use of selenium \[se\] supplements greater than the 100 mcg dose common in multivitamins between 30 days before study drug initiation and day 84 * history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent (e.g., reaction to other se supplements) * participants who have donated 1 unit of blood within 30 days prior to the first dose of investigational agent * eastern cooperative oncology group (ecog) performance status \> 1 * diagnosed with cancer, other than non-melanoma skin cancer, in last 2 years * under treatment for any cancer * use of glucose-lowering agents or a condition that would make a fast from 10:00 pm the evening before until 11:00 am on days 1 and 84 hazardous * american urological association (aua) total symptom score \> 10 or any individual symptom score of greater than or equal to 4 * psychiatric illness which would prevent compliance with the intervention or would prevent the patient from providing informed consent * medical conditions which in the opinion of the treating physician would make this protocol unreasonably hazardous for the participant