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

NCT01317199 | Completed Phase 1 Results DMC

• 1 other identifier: J1161
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 8

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.

Conditions

Prostate Cancer

Keywords

Rising psa

Outcome Measures

Primary Outcomes (2)

• (Phase I) Maximum Tolerated Dose

  To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.

  Up to 7 months post-intervention

• (Phase II) Prostate Specific Antigen Doubling Time (PSADT)

  To define the effects of placebo and two different daily doses of MPX on PSADT in men who have rising PSA after initial definitive therapy for localized prostate cancer.

  Change from baseline to month 12

Secondary Outcomes (3)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  At month 12 post-intervention

• (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%

  At month 12 post-intervention

• (Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline

  At month 12 post-intervention

Study Arms (4)

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

EXPERIMENTAL

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.

Drug: Muscadine Plus Grape Skin Extract

Phase 2: Placebo control

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Phase 2: Low-dose MPX

EXPERIMENTAL

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

Drug: Low-dose MPX

Phase 2: High-dose MPX

EXPERIMENTAL

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

Drug: High-dose MPX

Interventions

Muscadine Plus Grape Skin Extract DRUG

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

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

Low-dose MPX 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: Low-dose MPX

High-dose MPX DRUG

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

Phase 2: High-dose MPX

Placebo oral capsule 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: Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Howard University: collaborator
• Prostate Cancer Clinical Trials Consortium: collaborator

Study Sites (8)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Howard University College of Medicine

Washington D.C., District of Columbia, 20060, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Channing Paller
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

cpaller1@jhmi.edu

410-955-8239

Study Officials

• Michael A Carducci, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase 1 (Arms 1) - open label Phase 2 (Arms 2-4) - randomized, double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-dose

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 17, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 2, 2021
• Results First Posted: July 18, 2018

Record last verified: 2018-06

Locations

US (8)