Phase
Condition
Adenocarcinoma
Prostate Cancer
Treatment
Standard Anti-Cancer Diet
Usual Diet
Fasting Mimicking Diet (FMD)
Clinical Study ID
Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostatehistologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRIscan)
Men receiving or planning to start first-line intensified ADT (within 30 days ofregistration) with abiraterone, apalutamide, enzalutamide, or darolutamide with orwithout current or prior chemotherapy
Reads, writes, and understands English or Spanish and has telephone access forremote contact with the study dietitian.
Written informed consent obtained from subject and ability for subject to complywith the requirements of the study.
Exclusion
Exclusion Criteria:
Allergies to any ingredients listed on the Xentigen Ingredient List
Men with diabetes who are not on stable doses of antihyperglycemic medication for atleast 6 months and without physician consent that they may safely holdantihyperglycemic medication during the 5 days of FMD
Regularly practicing a fasting diet that in the opinion of the study physician wouldimpact study participation
Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoingalcohol/drug abuse) that in the opinion of the study physician would precludeenrollment in this study.
Body Mass Index (BMI) <20kg/m2
Men actively trying to lose weight OR on weight loss medications (including but notlimited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery inthe next six months
Self-reported weight loss ≥ 10% in the last 6 months
Study Design
Connect with a study center
Beckman Research Institute of the City of Hope
Duarte, California 91010
United StatesActive - Recruiting
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27710
United StatesActive - Recruiting
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