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Trial record 1 of 2 for:    johns hopkins AND mpx AND cancer
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Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01317199
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : July 18, 2018
Last Update Posted : April 2, 2021
Sponsor:
Collaborators:
Howard University
Prostate Cancer Clinical Trials Consortium
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE March 11, 2011
First Posted Date  ICMJE March 17, 2011
Results First Submitted Date  ICMJE May 14, 2018
Results First Posted Date  ICMJE July 18, 2018
Last Update Posted Date April 2, 2021
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • (Phase I) Maximum Tolerated Dose [ Time Frame: Up to 7 months post-intervention ]
    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) Prostate Specific Antigen Doubling Time (PSADT) [ Time Frame: Change from baseline to month 12 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
Maximum Tolerated Dose [ Time Frame: Approximately 7 months to reach MTD ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: At month 12 post-intervention ]
    Adverse events reported verbally by patient and documented in study notes.
  • (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33% [ Time Frame: At month 12 post-intervention ]
  • (Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline [ Time Frame: At month 12 post-intervention ]
    Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Investigator)
Masking Description:
Phase 1 (Arms 1) - open label Phase 2 (Arms 2-4) - randomized, double-blind
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Muscadine Plus Grape Skin Extract
    Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle
  • 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).
  • 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).
  • 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).
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Muscadine Plus Grape Skin Extract
  • Placebo Comparator: 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).
    Intervention: Drug: Placebo oral capsule
  • Experimental: Phase 2: Low-dose MPX
    Randomly-assigned participants receive low-dose (500mg) MPX
    Intervention: Drug: Low-dose MPX
  • Experimental: Phase 2: High-dose MPX
    Randomly-assigned participants receive high-dose (4000mg) MPX
    Intervention: Drug: High-dose MPX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2018)
143
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2011)
114
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01317199
Other Study ID Numbers  ICMJE J1161
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Responsible Party Michael Carducci, MD, Professor, SOM Urologic Oncology
Current Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Howard University
  • Prostate Cancer Clinical Trials Consortium
Investigators  ICMJE
Principal Investigator: Michael A Carducci, MD Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP