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

NCT01497431 | Completed Phase 1 DMC

• 6 other identifiers: NCI-2012-00085CDR0000717828I 182210NWU09-4-03P30CA060553N01CN35157
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

No Evidence of Disease; Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• Clinical toxicity of Se-methyl-seleno-L-cysteine according to the NCI CTCAE version 4.0

  The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.

  Up to 112 days

• Clinical toxicity of Se-methyl-L-cysteine compared to selenium after multiple doses, according to the NCI CTCAE version 4.0

  The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.

  Up to 112 days

Secondary Outcomes (1)

• Characterization of the pharmacokinetics of Se in the forms Se-methyl-seleno-L-cysteine and selenium at multiple doses

  At baseline, and at and .5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hrs after dosing on days 1 and between days 70 and 84

Study Arms (3)

Arm I (Se-methyl-seleno L-cysteine)

EXPERIMENTAL

Participants receive Se-methyl-seleno L-cysteine on days 1-84.

Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Methylselenocysteine

Arm II (selenomethionine)

EXPERIMENTAL

Participants receive selenomethionine PO on days 1-84.

Dietary Supplement: Selenium; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Arm III (placebo)

PLACEBO COMPARATOR

Participants receive placebo PO on days 1-84.

Other: Placebo; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Selenium DIETARY_SUPPLEMENT

Given PO

Also known as: Se

Arm II (selenomethionine)

Placebo OTHER

Given PO

Also known as: PLCB

Arm III (placebo)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (Se-methyl-seleno L-cysteine); Arm II (selenomethionine); Arm III (placebo)

Pharmacological Study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I (Se-methyl-seleno L-cysteine); Arm II (selenomethionine); Arm III (placebo)

Methylselenocysteine DRUG

Given PO

Also known as: L-Se-Methylselenocysteine, Methylselenocycteine, MSC, Se-Methyl-seleno-L-cysteine, SeMSC

Arm I (Se-methyl-seleno L-cysteine)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Selenium; selenomethylselenocysteine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Raymond Bergan

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

US (3)