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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317199
• Other study ID #: J1161
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2011
• Est. completion date: November 2015

Study information

• Verified date: June 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Muscadine Plus Grape Skin Extract
Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle
• 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).
• High-dose MPX
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
• 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).

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Howard University College of Medicine	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Howard University, Prostate Cancer Clinical Trials Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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.	Up to 7 months post-intervention
Primary	(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.	Change from baseline to month 12
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Adverse events reported verbally by patient and documented in study notes.	At month 12 post-intervention
Secondary	(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%		At month 12 post-intervention
Secondary	(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	At month 12 post-intervention