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NCT03679260 · ClinicalTrials.gov registry record · Phase 2
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT03679260: Completed Phase 2 study, sponsored by Cedars-Sinai Medical Center.
NCT03679260 is a Phase 2 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03679260, a Phase 2 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.
Primary Outcome
Proliferative index is measured by Ki67/apoptosis rate
Interventions
- OTHER Carbohydrate restricted diet
- OTHER Non-restricted diet
- OTHER Phone counseling with dietitian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2023-03-24 |
| Phase | Phase 2 |
What the finished NCT03679260 record still lists
NCT03679260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Carbohydrate restricted diet is the first listed.
NCT03679260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03679260 about?
NCT03679260 is a clinical study titled "Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance". This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over...
What is the current status of trial NCT03679260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-09-25. Estimated completion is 2023-03-24.
What interventions are being tested in trial NCT03679260?
The interventions under investigation include: Carbohydrate restricted diet (OTHER), Non-restricted diet (OTHER), Phone counseling with dietitian (OTHER).
Who is sponsoring clinical trial NCT03679260?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03679260's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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