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 capsule on rising prostate-specific antigen in men following initial therapy for prostate cancer
This research is being done to find safe levels and test the safety of Muscasine Plus (MPX) capsules in men with prostate cancer. MPX is made from Muscadine grape skins that have been dried and ground into powder. Some studies suggest that grape skins contain natural compounds that are active against prostate cancer. We will explore MPX to see if there is a minimum dose that can affect PSA levels, or whether high doses have a bigger effect on PSA levels or more side effects. You will be monitored by regular visits for potential side effects while enrolled in the study.
Men with adenocarcinoma of the prostate. Men that have undergone prior treatment with surgery, surgery with radiation therapy, cryotherapy, radiation or brachytherapy for the primary prostate tumor. The patient must have a risng PSA at 3 time points within 12 months prior to starting the study. The time points must be at least 21 days apart. Men age 18 years or older. Good overall performace status, normal organ and marrow function. The patient must pass all screening activities at the clinic visit. The person must abstain from other commercially available MuscadinePlus (MP) products (Vinetra, MPlus or MP capsules) while participating in this study. Stable use of other dietary supplements for 2 months (saw palmetto, selenuim, pomegranate, ect) Signed consent form as well as passing the study clinic visits and agrees to comply with the follow up visits.
You will take 1,2,4,6, or 8 capsules of MPX once each day for 28 days in the inital Phase I portion of the study. You will be asked to come to the clinic every two weeks to pick up additional pills and have bloodwork collected. In order to understand how MPX is absorbed by the body, the first day multiple blood samples will be obtained as well as urine. You will have monthly physical exams with your cancer doctor as well as routine PSA and labwork collected at that time. You will be asked about your overall health history and at times you will be asked to complete a food frequency questionnaire. The patient will be in the study about 20 months or longer, you may come off the study at any time.
05/18/2013 04:02 AM