Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
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: October 28, 2014
Last verified: October 2014

March 11, 2011
October 28, 2014
July 2011
November 2015   (final data collection date for primary outcome measure)
  • (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.
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
Complete list of historical versions of study NCT01317199 on ClinicalTrials.gov Archive Site
  • (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.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

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

Experimental: Muscadine Plus Grape Skin Extract
Intervention: Drug: Muscadine Plus Grape Skin Extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
139
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.
  • 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)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01317199
J1161
Yes
Michael A. Carducci, MD, Johns Hopkins University
Johns Hopkins University
  • Howard University
  • Department of Defense: Prostate Cancer Clinical Trial Consortium
Principal Investigator: Michael A Carducci, MD Johns Hopkins University
Johns Hopkins University
October 2014

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