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NCT01433913 · ClinicalTrials.gov registry record · Phase 2

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT01433913: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01433913 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01433913, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well metformin hydrochloride works compared to placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells.

Primary Outcome

Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. If the data are not normally distributed, a non-parametric rank-sum test will be utilized.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER placebo
  • DRUG metformin hydrochloride

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-11
Est. Completion 2014-04
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01433913 record still lists

NCT01433913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT01433913 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01433913 about?

NCT01433913 is a clinical study titled "Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery". This randomized phase II trial studies how well metformin hydrochloride works compared to placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tu...

What is the current status of trial NCT01433913?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-11. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01433913?

The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), metformin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01433913?

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 NCT01433913's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01433913, the US trial registry maintained by the National Library of Medicine. NCT01433913 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.