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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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

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No Evidence of Disease Prostate Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type OTHER

Correlative studies

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Se PLCB pharmacological studies L-Se-Methylselenocysteine Methylselenocycteine MSC Se-Methyl-seleno-L-cysteine SeMSC

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond Bergan

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States