Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

Inclusion Criteria:

• Men age ≥18 years who are fluent in English.

• Histologically confirmed prostate adenocarcinoma.

• Prior surgical castration or active ongoing use of androgen deprivation therapy (ADT) with expectation by the treating physician that patient would remain on ADTfor the upcoming 12 months. ADT in the setting of definitive radiation therapypermitted. Concurrent treatment with androgen pathway inhibitors (examples includeenzalutamide, abiraterone, darolutamide, apalutamide) permitted..

• Normal organ and marrow function function (labs within 30 days prior to study entry)as defined below:

White blood cell count greater than or equal to 3,500/mcL (or 3.5 (x103)) Platelet count greater than or equal to 75,000/mcL (or 75 (x103)) Hemoglobin greater than or equal to >9 g/dL Total bilirubin less than or equal to 2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal Creatinine less than or equal to 2.5 X institutional upper limit of normal

• Able to ambulate (use of assist device is acceptable).

• Able to cooperate with study-related activities.

• The effects of MGE on the developing human fetus are unknown. Men must agree to useadequate contraception (barrier method of birth control; abstinence) prior to studyentry and for the duration of study participation.

• Ability to understand and the willingness to sign an IRB-approved informed consentdocument (either directly or via a legally authorized representative).

Exclusion Criteria:

• Symptomatic metastatic disease requiring medical treatment (i.e., painful metastasesto bone).

• Prostate cancer related surgery or radiation within 60 days prior to study entry.

• Documented rise in PSA (defined as rise of > 0.5 ng/mL) while on current prostatecancer therapy, determined by PSA values, at least one of which must be during the 6months prior to study entry PSA values must be at least 7 days apart.

• Planned cessation of ADT or planned use of cytotoxic chemotherapy (i.e., docetaxel)within 12 months after study entry.

• Ongoing use of any other investigational cancer-directed agents.

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to MGE.

• Inability to swallow oral medications.

• Malabsorption due to bowel resection or gastrointestinal disease leading touncontrolled diarrhea, or persistent nausea or vomiting requiring daily antiemetictherapy for symptom management within the past week.

• Uncontrolled intercurrent illness, including but not limited to: ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.