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Active Not Recruiting
NCT05471414
Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
Conditions: Prostate Cancer
Sex: Male
Ages: 45 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 76
Sponsor: Weill Medical College of Cornell University
Location: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
Summary
The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).
Eligibility Criteria
Inclusion Criteria
1. Histologically or cytologically confirmed adenocarcinoma of the prostate
2. Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible.
3. On ADT for at least 24 weeks pre-study with anticipation of at least 26 more weeks of therapy from the date of initiation of the dietary intervention
4. Patients receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) are eligible if they have been on therapy for at least 3 months and plan to continue for the duration of the study
5. At least 3 months post completion of chemotherapy and/or radiation
6. Bone resorptive agents such as bisphosphanates and denosumab are allowed.
7. Testosterone level \
Source: ClinicalTrials.gov (NCT05471414). StuddyBuddy aggregates publicly available trial information.