Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 22 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03679260
The ClinicalTrials.gov registry entry for NCT03679260 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carbohydrate restricted diet is the first listed.
NCT03679260 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.