Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

NCT ID: NCT01317199

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-11-30

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract

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.

Group Type: EXPERIMENTAL

Muscadine Plus Grape Skin Extract

Intervention Type: DRUG

Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle

Phase 2: Placebo control

Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).

Phase 2: Low-dose MPX

Randomly-assigned participants receive low-dose (500mg) MPX

Group Type: EXPERIMENTAL

Low-dose MPX

Intervention Type: DRUG

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).

Phase 2: High-dose MPX

Randomly-assigned participants receive high-dose (4000mg) MPX

Group Type: EXPERIMENTAL

High-dose MPX

Intervention Type: DRUG

Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).

Interventions

Muscadine Plus Grape Skin Extract

Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle

Intervention Type: DRUG

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).

Intervention Type: DRUG

High-dose MPX

Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Howard University

OTHER

Sponsor Role: collaborator

Prostate Cancer Clinical Trials Consortium

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Carducci, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Howard University College of Medicine

Washington D.C., District of Columbia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

J1161

Identifier Type: -

Identifier Source: org_study_id