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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johns Hopkins University
Sponsor:
Collaborators:
Howard University
Department of Defense: Prostate Cancer Clinical Trial Consortium
Information provided by (Responsible Party):
Michael A. Carducci, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01317199
First received: March 11, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Muscadine Plus Grape Skin Extract
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • (Phase I) Maximum Tolerated Dose [ Time Frame: Approximately 7 months to reach MTD ] [ Designated as safety issue: Yes ]
    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

  • (Phase II) Define the effects of placebo and two different daily doses of Muscadine Plus on PSA doubling time [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    To define the effects of placebo and two different daily doses of Muscadine Plus (MPX) on prostate specific antigen doubling time (PSADT) in men who have rising PSA after initial definitive therapy for localized prostate cancer.


Secondary Outcome Measures:
  • (Phase I)Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • (Phase II) To estimate other measures of PSA kinetics [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    (1) To estimate other measures of PSA kinetics including a)log PSA slope, b) PSAV, c) proportion of men whose PSADT increases greater than 33%, and d)greater than 50% reduction in PSA compared with baseline.


Estimated Enrollment: 139
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Muscadine Plus Grape Skin Extract Drug: Muscadine Plus Grape Skin Extract

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

Phase II: to be determined after maximum tolerated dose in Phase I is established


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317199

Contacts
Contact: Serina King 410-614-6139 sking18@jhmi.edu
Contact: Donna Dowling, RN 410-614-9526 ddowlin1@jhmi.edu

Locations
United States, District of Columbia
Howard University College of Medicine Recruiting
Washington, District of Columbia, United States, 20060
Contact: Anita Aggarwal, D.O., Ph.D    202-865-1925    aaggarwal@howard.edu   
Principal Investigator: Anita Aggarwal, DO., Ph.D         
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Channing Paller, MD       cpaller1@jhmi.edu   
Contact: Ruth Chamberlain, RN    202-364-7620    rchamberlain@sibley.org   
Principal Investigator: Channing Paller, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Donna Dowling, RN    410-614-9526    ddowlin1@jhmi.edu   
Contact: Serina King    410-614-6139    sking18@jhmi.edu   
Principal Investigator: Channing Paller, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Glen Bubley, MD    617-667-2404    gbubley@caregroup.harvard.edu   
Contact: Stephen Duggan    617-632-9281    sduggan@bidmc.harvard.edu   
Sub-Investigator: Glen Bubley, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mary Taplin, MD    617-632-3237    mary.taplin@dfci.harvard.edu   
Contact: Max Hazeltine    617-632-2389    maxd_hazeltine@dfci.harvard.edu   
Principal Investigator: Mary Taplin, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Elisabeth Heath, MD    313-576-9837    heathe@karmanos.org   
Contact: Kim Dobson    313-576-9837    dobsonk@karmanos.org   
Principal Investigator: Elisabeth Heath, MD         
United States, New Jersey
Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Tina Mayer, MD    732-235-9567    mayertm@umdnj.edu   
Contact: Monika Anand, Ph.D    732-235-9567    anandmo@umdnj.edu   
Principal Investigator: Tina Mayer, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: ROBERTO PILI, MD    716-845-3117    ROBERTO.PILI@ROSWELLPARK.ORG   
Contact: DIANE POSLINSKI, RN    716-845-7754    DIANE.POSLINSKI@ROSWELLPARK.ORG   
Principal Investigator: Roberto Pili, MD         
Sponsors and Collaborators
Johns Hopkins University
Howard University
Department of Defense: Prostate Cancer Clinical Trial Consortium
Investigators
Principal Investigator: Michael A Carducci, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Michael A. Carducci, MD, Aegon Professor of Oncology and Urology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01317199     History of Changes
Other Study ID Numbers: J1161
Study First Received: March 11, 2011
Last Updated: March 4, 2014
Health Authority: United States: Johns Hopkins University Safety Monitoring Committee

Keywords provided by Johns Hopkins University:
Rising psa

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014