Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
192

Summary

Conditions
Recurrent Prostate Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Masking Description: This is a double-blind study. Only the lead-site investigational pharmacy team and the statistician will unblinded. The blind will be maintained until the study is complete.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

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 plac...

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.

Tracking Information

NCT #
NCT03496805
Collaborators
Not Provided
Investigators
Principal Investigator: Heidi Klepin, MD Wake Forest University Health Sciences