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NCT01543776 · ClinicalTrials.gov registry record · Phase 2

Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer

A Phase 2 study, sponsored by University of Chicago.

Completed
Registry status
Phase 2
Development phase
72
Enrollment target

NCT01543776: Completed Phase 2 study, sponsored by University of Chicago.

NCT01543776 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01543776, a Phase 2 study, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
72 participants
Enrollment target

Study Summary

This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.

Primary Outcome

Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.

Interventions

  • DRUG abiraterone acetate

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2012-01
Est. Completion 2017-12
Phase Phase 2
University of Chicago

796 total trials

What the finished NCT01543776 record still lists

NCT01543776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).

The record links to 0 conditions, and to 1 intervention - of which abiraterone acetate is the first listed.

NCT01543776 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01543776 about?

NCT01543776 is a clinical study titled "Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer". This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abirate...

What is the current status of trial NCT01543776?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2012-01. Estimated completion is 2017-12.

What interventions are being tested in trial NCT01543776?

The interventions under investigation include: abiraterone acetate (DRUG).

Who is sponsoring clinical trial NCT01543776?

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 NCT01543776's enrollment target sits among peer trials

72 925th of 2000 higher than 1,065 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 NCT01543776, the US trial registry maintained by the National Library of Medicine. NCT01543776 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.