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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

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ClinicalTrials.gov Identifier: NCT01317199
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Howard University
Prostate Cancer Clinical Trials Consortium
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

March 11, 2011
March 17, 2011
May 14, 2018
July 18, 2018
July 18, 2018
July 2011
November 2015   (Final data collection date for primary outcome measure)
  • (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.
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
Complete list of historical versions of study NCT01317199 on ClinicalTrials.gov Archive Site
  • 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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 3 years ]
Not Provided
Not Provided
 
Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
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
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.
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
Interventional
Phase 1
Phase 2
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
Prostate Cancer
  • 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).
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
114
November 2015
November 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01317199
J1161
Yes
Not Provided
Not Provided
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Howard University
  • Prostate Cancer Clinical Trials Consortium
Principal Investigator: Michael A Carducci, MD Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
June 2018

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