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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

(Phase I) Maximum Tolerated Dose

Outcome 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

Outcome Time Frame:

Approximately 7 months to reach MTD

Safety Issue:

Yes

Principal Investigator

Michael A Carducci, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Johns Hopkins University Safety Monitoring Committee

Study ID:

J1161

NCT ID:

NCT01317199

Start Date:

July 2011

Completion Date:

June 2014

Related Keywords:

  • Prostate Cancer
  • Rising psa
  • Prostatic Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Sibley Memorial HospitalWashington, District of Columbia  20016
Howard University College of MedicineWashington, District of Columbia  20059
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Johns Hopkins HospitalBaltimore, Maryland  21287