Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
Status and phase
Completed
Phase 2
Phase 1
Conditions
Prostate Cancer
Treatments
Drug: High-dose MPX
Drug: Placebo oral capsule
Drug: Low-dose MPX
Drug: Muscadine Plus Grape Skin Extract
Details and patient eligibility
About
This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.
Full description
In phase I the investigators are evaluating the safety of the product and checking blood levels of the active components. In phase II the investigators are evaluating the effect of MPX on PSA doubling time
Enrollment
143 patients
Sex
Male
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.
- Rising PSA on a minimum of 3 time points (including screening psa) within the 12 months prior to study initiation.
- > 18 years of age.
- Life expectancy of greater than 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Testosterone level of ≥1.5 ng/mL at screening.
- Adequate kidney, liver and bone marrow function
- Agrees to abstain from other commercially available MP products while participating in this study.
- Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose(s) while participating in the study.
- Signed a written informed consent document and agrees to comply with requirements of the study.
Exclusion criteria
- Known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 2.0 cm maybe considered nonspecific and the patient would be eligible
- Receipt of any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 6 months prior to study
- Prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product
- Consumption of Muscadine Plus over the past 2 months
- Known allergy to muscadine grapes or ellagic acid
- 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
- Negative PSA doubling time (1 time point may be excluded per 3e inclusion criteria)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
143 participants in 4 patient groups, including a placebo group
Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract
Experimental group
Description:
Muscadine Plus Grape Skin Extract (MPX): Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
Treatment:
Drug: Muscadine Plus Grape Skin Extract
Phase 2: Placebo control
Placebo Comparator group
Description:
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Treatment:
Drug: Placebo oral capsule
Phase 2: Low-dose MPX
Experimental group
Description:
Randomly-assigned participants receive low-dose (500mg) MPX
Treatment:
Drug: Low-dose MPX
Phase 2: High-dose MPX
Experimental group
Description:
Randomly-assigned participants receive high-dose (4000mg) MPX
Treatment:
Drug: High-dose MPX
Trial contacts and locations
8
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Data sourced from clinicaltrials.gov
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