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NCT01238172 · ClinicalTrials.gov registry record · Phase 3
Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
NCT01238172: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01238172 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01238172, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer. PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
Primary Outcome
Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the
Interventions
- OTHER dietary education and counseling
- OTHER prostate cancer foundation booklet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2011-01 |
| Est. Completion | 2019-01-15 |
| Phase | Phase 3 |
What the finished NCT01238172 record still lists
NCT01238172 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which dietary education and counseling is the first listed.
NCT01238172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01238172 about?
NCT01238172 is a clinical study titled "Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance". RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer. PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
What is the current status of trial NCT01238172?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2011-01. Estimated completion is 2019-01-15.
What interventions are being tested in trial NCT01238172?
The interventions under investigation include: dietary education and counseling (OTHER), prostate cancer foundation booklet (OTHER).
Who is sponsoring clinical trial NCT01238172?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01238172's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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