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NCT05832086 · ClinicalTrials.gov registry record · Phase 2
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
A Phase 2 study of Prostate Adenocarcinoma, sponsored by Stephen Freedland.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 3
- Study locations
NCT05832086: Recruiting Phase 2 study of Prostate Adenocarcinoma, sponsored by Stephen Freedland.
NCT05832086 is a Phase 2 study of Prostate Adenocarcinoma that is actively recruiting participants, run by Stephen Freedland. The registered enrollment target is 138 participants, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (36% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05832086, a Phase 2 study of Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Stephen Freedland.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians. This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.
Primary Outcome
Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir.
Conditions Studied
Interventions
- BEHAVIORAL Fasting Mimicking Diet (FMD)
- BEHAVIORAL Standard Anti-Cancer Diet
Study Locations (3)
California
- Beckman Research Institute of the City of Hope - Duarte
- Cedars-Sinai Medical Center - Los Angeles
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2023-09-13 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 2 |
What NCT05832086 shows while recruiting
NCT05832086 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (36% lower).
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Fasting Mimicking Diet (FMD) is the first listed.
NCT05832086 reports a single indexed study location in California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05832086 about?
NCT05832086 is a clinical study titled "Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes". This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. ...
What is the current status of trial NCT05832086?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2023-09-13. Estimated completion is 2029-03-30.
What conditions does trial NCT05832086 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma.
What interventions are being tested in trial NCT05832086?
The interventions under investigation include: Fasting Mimicking Diet (FMD) (BEHAVIORAL), Standard Anti-Cancer Diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT05832086?
This trial is sponsored by Stephen Freedland, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05832086 being conducted?
This trial has 3 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05832086's enrollment target sits among peer trials
138 29th of 99 higher than 71 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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.
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