Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
It is estimated that one-third of the more than 7 million deaths from cancer worldwide are
 attributable to potentially modifiable risk factors, with 374,000 deaths preventable through
 diet modification alone. Diet supplementation for the prevention or treatment of cancer is
 attractive, as implementation is relatively easy, even in populations with reduced incomes
 and resources. Grape extracts or active components isolated from grapes have received
 attention as chemopreventive or therapeutic agents based upon their anti-proliferative,
 anti-inflammatory, and anti-oxidant properties. Evidence from preclinical trials also
 suggests that muscadine grape products may decrease systemic inflammation. This study builds
 upon promising preclinical and clinical evidence to determine if the addition muscadine grape
 extract (MGE) to androgen deprivation therapy (ADT) improves symptoms in men with prostate
 cancer.
Primary Objective: To compare levels of fatigue in the MGE group compared to the placebo
 group at 6 months.

 Secondary Objectives

 -  To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and
 12 months.

 -  To compare quality of life in men in the MGE group compared to the placebo group.

 -  To compare physical function, physical fitness, and body composition in men in the MGE
 group compared to the placebo group.

 -  To compare time to PSA progression (from study entry) in men in the MGE group compared
 to the placebo group.

 -  To compare progression-free survival (from study entry) in men in the MGE group compared
 to the placebo group.

 OUTLINE: Participants are randomized into 1 of 2 groups.

 GROUP I (Muscadine grape extract): Participants begin Androgen deprivation therapy prior to
 receiving muscadine grape extract and then receive muscadine grape extract orally (PO) twice
 daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity.

 GROUP II (PLACEBO): Participants begin Androgen deprivation therapy 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 at 72 hours and then for up
 to 12 months.
Inclusion Criteria:

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

 -  Histologically confirmed prostate adenocarcinoma.

 -  Definitive therapy of primary prostate tumor completed. Definitive therapy can be
 prostatectomy, primary radiation therapy, brachytherapy, or cryotherapy. Salvage
 radiation after prostatectomy is allowed, if completed >60 days prior to study entry.

 -  Prior surgical castration or active use of androgen deprivation therapy (ADT) alone,
 with expectation by the treating physician that patient would remain on ADT alone for
 upcoming 12 months, without escalating therapy. Prior ADT in the setting of definitive
 radiation therapy permitted.

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

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

 -  Any cancer treatment other than ADT within 30 days prior to study entry.

 -  Documented rise in PSA (defined as rise of > 0.5 ng/mL) while on continuous ADT
 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 escalation of prostate cancer therapy 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.