About this trial
This study looks at how a special fasting diet can help men with metastatic castrate sensitive prostate cancer. It is a Phase 2 trial involving 138 patients. Half of the participants will follow the fasting mimicking diet, while the other half will eat their usual diet. Everyone will receive standard treatment for their cancer during the study, which lasts for six months.
This is Phase 2 research, which means it is looking at how well the treatment works and its safety. The trial is not for drugs or devices regulated by the FDA. The goal is to include 138 participants.
Who can join
Men aged 18 and older with confirmed metastatic castrate sensitive prostate adenocarcinoma can join. They need to be starting their first treatment with specific medications. Participants must be able to read and understand English or Spanish and have access to a phone. Some health issues may prevent participation, and those with certain allergies or weight loss goals cannot join. The trial team will confirm who is eligible.
Condition
Prostate Adenocarcinoma
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into two groups by chance. One group will follow a fasting mimicking diet for five days each month for six months. The other group will continue with their standard anti-cancer diet. Both groups will receive regular support from dietitians to help with their diet and health during the study.
Where
This trial is running at 3 locations in the United States. All of them are currently recruiting.
Beckman Research Institute of the City of Hope
Duarte, California
Cedars-Sinai Medical Center
Los Angeles, California
Duke University
Durham, North Carolina