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

Completed · Phase 1 · Has a placebo group

Conditions studied: No Evidence of Disease, Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT01497431

Run by

National Cancer Institute (NCI)

People needed

66

Starts

2011-11-01

Expected to finish

2014-07-01

Last updated by the study team

2014-11-26

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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