Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men with Prostate Cancer: A Randomized, Double-Blind Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer: Phase II

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Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men with Prostate Cancer: A Randomized, Double-Blind Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer: Phase II

Phase II Primary Objective: To define the effects of placebo and two different daily doses of Muscadine Plus (MPX) on prostate specific antigen doubling time (PSADT) in men who have rising PSA after initial definitive therapy for localized prostate cancer.
Phase II Secondary Objectives: (1) To estimate other measures of PSA kinetics including a)log PSA slope, b)PSAV, c)proportion of men whose PSADT increases greater than 33%, d)greater than 50% reduction in PSA compared with baseline. (2) To assess the adherence, tolerability and toxicity of MPX in both arms of the study.

Protocol Number081205
Principal InvestigatorTina Mayer
PhasePhase I/II
ScopeNational
Applicable Disease SitesProstate
Therapies InvolvedTherapy (NOS)
Chemotherapy single agent systemic
Drugs InvolvedPLACEBO
Muscadine Plus (MPX)
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.