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NCT01023061 · ClinicalTrials.gov registry record · Phase 2
Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01023061: Completed Phase 2 study, sponsored by University of Washington.
NCT01023061 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01023061, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
Primary Outcome
Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.
Interventions
- OTHER laboratory biomarker analysis
- DRUG abiraterone acetate
- DRUG prednisone
- DRUG leuprolide acetate
- RADIATION external beam radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01023061 record still lists
NCT01023061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01023061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01023061 about?
NCT01023061 is a clinical study titled "Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer". This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. A...
What is the current status of trial NCT01023061?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-03. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01023061?
The interventions under investigation include: laboratory biomarker analysis (OTHER), abiraterone acetate (DRUG), prednisone (DRUG), leuprolide acetate (DRUG), external beam radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT01023061?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01023061's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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