Clinical trial NCT01317199: Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Rising psa
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Howard University
name: Prostate Cancer Clinical Trials Consortium
First posted: 2011-03-17
Enrollment: 143
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-dose
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: (Phase I) Maximum Tolerated Dose
timeFrame: Up to 7 months post-intervention
measure: (Phase II) Prostate Specific Antigen Doubling Time (PSADT)
timeFrame: Change from baseline to month 12
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: At month 12 post-intervention
measure: (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%
timeFrame: At month 12 post-intervention
measure: (Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline
timeFrame: At month 12 post-intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Washington
country: United States
facility: Howard University College of Medicine
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Johns Hopkins University
name: Michael A Carducci, MD
role: PRINCIPAL_INVESTIGATOR
References: