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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Muscadine Plus Grape Skin Extract
Low-dose MPX
High-dose MPX
Placebo oral capsule
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Rising psa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Sibley Memorial Hospital
  • Howard University College of Medicine
  • Johns Hopkins Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Karmanos Cancer Institute
  • Cancer Institute of New Jersey
  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

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

Phase 2: Placebo control

Phase 2: Low-dose MPX

Phase 2: High-dose MPX

Arm Description

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.

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

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

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

Outcomes

Primary Outcome Measures

(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.
(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.

Secondary Outcome Measures

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events reported verbally by patient and documented in study notes.
(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%
(Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline
Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL

Full Information

First Posted
March 11, 2011
Last Updated
April 1, 2021
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Howard University, Prostate Cancer Clinical Trials Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT01317199
Brief Title
Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Howard University, Prostate Cancer Clinical Trials Consortium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Rising psa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Phase 1 (Arms 1) - open label Phase 2 (Arms 2-4) - randomized, double-blind
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2: Placebo control
Arm Type
Placebo Comparator
Arm Description
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Arm Title
Phase 2: Low-dose MPX
Arm Type
Experimental
Arm Description
Randomly-assigned participants receive low-dose (500mg) MPX
Arm Title
Phase 2: High-dose MPX
Arm Type
Experimental
Arm Description
Randomly-assigned participants receive high-dose (4000mg) MPX
Intervention Type
Drug
Intervention Name(s)
Muscadine Plus Grape Skin Extract
Intervention Description
Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle
Intervention Type
Drug
Intervention Name(s)
Low-dose MPX
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
High-dose MPX
Intervention Description
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Primary Outcome Measure Information:
Title
(Phase I) Maximum Tolerated Dose
Description
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.
Time Frame
Up to 7 months post-intervention
Title
(Phase II) Prostate Specific Antigen Doubling Time (PSADT)
Description
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.
Time Frame
Change from baseline to month 12
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
Adverse events reported verbally by patient and documented in study notes.
Time Frame
At month 12 post-intervention
Title
(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%
Time Frame
At month 12 post-intervention
Title
(Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline
Description
Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL
Time Frame
At month 12 post-intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Carducci, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Howard University College of Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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