Muscadine grape extract for men with prostate cancer on hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of muscadine grape extract (MGE) on men undergoing androgen deprivation therapy (ADT) for recurrent prostate cancer. Participants are randomly assigned to receive either MGE or a placebo alongside their ADT for 12 months. The primary focus is to assess fatigue levels at 6 months, with secondary objectives including quality of life, physical function, body composition, and progression-free survival. The study aims to build on previous evidence suggesting that grape extracts may have beneficial effects on cancer treatment outcomes.

Why it matters

Who can join: the full rules

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 ADT for the upcoming 12 months. ADT in the setting of definitive radiation therapy permitted. Concurrent treatment with androgen pathway inhibitors (examples include enzalutamide, 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 use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

* Symptomatic metastatic disease requiring medical treatment (i.e., painful metastases to 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 prostate cancer therapy, determined by PSA values, at least one of which must be during the 6 months 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 or biologic composition to MGE.
* Inability to swallow oral medications.
* Malabsorption due to bowel resection or gastrointestinal disease leading to uncontrolled diarrhea, or persistent nausea or vomiting requiring daily antiemetic therapy for symptom management within the past week.
* Uncontrolled intercurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Where it's running

• WG Hefner VA Medical Center
  Salisbury, North Carolina, United States Recruiting
• Wake Forest Baptist Medical Center
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Heidi Klepin, MD — Wake Forest University Health Sciences
• Study coordinator: Katherine Pleasant
• Email: kpleasan@wakehealth.edu
• Phone: 3367135045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.