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NCT01497431 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT01497431: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01497431 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01497431, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study 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 Outcome

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.

Interventions

  • OTHER Placebo
  • OTHER Laboratory Biomarker Analysis
  • OTHER Pharmacological Study
  • DIETARY_SUPPLEMENT Selenium
  • DRUG Methylselenocysteine

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2011-11
Est. Completion 2014-07
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01497431 record still lists

NCT01497431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01497431 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01497431 about?

NCT01497431 is a clinical study titled "Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants". 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 seleno...

What is the current status of trial NCT01497431?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2011-11. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01497431?

The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Selenium (DIETARY_SUPPLEMENT), Methylselenocysteine (DRUG).

Who is sponsoring clinical trial NCT01497431?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01497431's enrollment target sits among peer trials

66 786th of 2000 higher than 1,203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01497431, the US trial registry maintained by the National Library of Medicine. NCT01497431 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.