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NCT00515112 · ClinicalTrials.gov registry record · Phase 2

Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

A Phase 2 study, sponsored by University of Chicago.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT00515112: Clinical Trial Phase 2 study, sponsored by University of Chicago.

NCT00515112 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00515112, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.

Primary Outcome

Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as s

Interventions

  • DRUG placebo
  • DRUG AndroGel

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2007-07
Est. Completion 2012-08
Phase Phase 2
University of Chicago

796 total trials

Why NCT00515112 stopped before completion

NCT00515112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00515112 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00515112 about?

NCT00515112 is a clinical study titled "Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer". The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.

What is the current status of trial NCT00515112?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-07. Estimated completion is 2012-08.

What interventions are being tested in trial NCT00515112?

The interventions under investigation include: placebo (DRUG), AndroGel (DRUG).

Who is sponsoring clinical trial NCT00515112?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00515112's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 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 NCT00515112, the US trial registry maintained by the National Library of Medicine. NCT00515112 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.