Muscadine Grape Extract in Treating Participants with Prostate Cancer on Androgen Deprivation Therapy
This phase II trial studies how well muscadine grape extract works in treating participants with prostate cancer on androgen deprivation therapy. Muscadine grape extract is a natural product that has potential anti-cancer properties and may improve androgen deprivation therapy-related fatigue.
Inclusion Criteria
- 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
- White blood cell count >= 3,500/mcL (or 3.5 [x 10^3]) (within 30 days prior to study entry)
- Platelet count >= 75,000/mcL (or 75 [x 10^3]) (within 30 days prior to study entry)
- Hemoglobin >= 9 g/dL (within 30 days prior to study entry)
- Total bilirubin =< 2.5 x institutional upper limit of normal (within 30 days prior to study entry)
- Aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine transferase (ALT) serum glutamate pyruvate transaminase (SGPT) =< 2.5 x institutional upper limit of normal (within 30 days prior to study entry)
- Creatinine =< 2.5 x institutional upper limit of normal (within 30 days prior to study entry)
- 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 Institutional Review Board (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: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03496805.
PRIMARY OBJECTIVE:
I. To compare levels of fatigue in the muscadine grape extract (MGE) group compared to the placebo group at 6 months.
SECONDARY OBJECTIVES:
I. To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and 12 months.
II. To compare quality of life in men in the MGE group compared to the placebo group.
III. To compare physical function, physical fitness, and body composition in men in the MGE group compared to the placebo group.
IV. To compare time to prostate-specific antigen (PSA) progression (from study entry) in men in the MGE group compared to the placebo group.
V. To compare progression-free survival (from study entry) in men in the MGE group compared to the placebo group.
EXPLORATORY OBJECTIVES:
I. To examine if differences in levels of fatigue at 6 months by intervention group vary in those participants who report meaningful fatigue at baseline compared to those who did not have meaningful fatigue at baseline.
II. To examine if differences in levels of fatigue at 6 months by intervention group vary by completing at least 80% of the dose for the full course of treatment (i.e., completing 12 months of treatment taking >= 80% of pills averaged over the 12 month period) compared to those who did not complete at least 80% of the dose for the full course of treatment.
III. To compare levels of circulating biomarkers of angiogenesis, inflammation, and oxidative stress at baseline, 6, and 12 months between the MGE and placebo groups.
IV. To compare phenolic levels and circulating phenolic metabolites at baseline, 6, and 12 months between the MGE and placebo groups.
V. To correlate PSA changes with changes in circulating biomarkers of angiogenesis, inflammation, oxidative stress, phenolic levels, and phenolic metabolites.
VI. To assess for the manganese superoxide dismutase genotype AA at baseline and to correlate genotype with fatigue and PSA levels at 6 months.
VII. To bank blood for the future study of prostate cancer-related biomarkers such as mitochondrial function, circulating exosomes, and tumor-derived micro ribonucleic acid (microRNA) at baseline, 6, and 12 months.
VIII. To examine if differences in levels of fatigue at 6 months by intervention group vary by androgen deprivation therapy (ADT) alone compared to those taking ADT plus at least one additional androgen-pathway directed therapy
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (MGE): Participants begin ADT prior to receiving MGE and then receive MGE orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity.
GROUP II (PLACEBO): Participants begin ADT prior to receiving placebo and then receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up for 72 hours and then for up to 12 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorHeidi Diana Klepin
- Primary IDCCCWFU 85417
- Secondary IDsNCI-2018-00579
- ClinicalTrials.gov IDNCT03496805