Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| No Evidence of Disease | — | UNRESOLVED | — |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Methylselenocysteine | Drug | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Selenium | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (Se-methyl-seleno L-cysteine)
- description
- Participants receive Se-methyl-seleno L-cysteine on days 1-84.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Drug: Methylselenocysteine
- type
- EXPERIMENTAL
- label
- Arm II (selenomethionine)
- description
- Participants receive selenomethionine PO on days 1-84.
- interventionNames
- Dietary Supplement: Selenium
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available