143
Participants
Start Date
July 31, 2011
Primary Completion Date
November 30, 2015
Study Completion Date
November 30, 2015
Muscadine Plus Grape Skin Extract
Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle
Low-dose MPX
Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
High-dose MPX
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Placebo oral capsule
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Roswell Park Cancer Institute, Buffalo
Sibley Memorial Hospital, Washington D.C.
Howard University College of Medicine, Washington D.C.
Johns Hopkins Hospital, Baltimore
Karmanos Cancer Institute, Detroit
Beth Israel Deaconess Medical Center, Boston
Dana Farber Cancer Institute, Boston
Cancer Institute of New Jersey, New Brunswick
Howard University
OTHER
Prostate Cancer Clinical Trials Consortium
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER