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Prostatic Neoplasms

Genital Neoplasms, Male

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Genital Diseases, Male

Urogenital Diseases

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Male Urogenital Diseases

Herbal and Botanical

All Drugs and Chemicals

Grape

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

Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle

Muscadine Plus Grape Skin Extract

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).

Low-dose MPX

Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).

High-dose MPX

Placebo oral capsule

Michael A Carducci, MD

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

Arm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-dose

Phase 1 (Arms 1) - open label Phase 2 (Arms 2-4) - randomized, double-blind

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

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.

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.

Adverse events reported verbally by patient and documented in study notes.

Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL

Howard University

Prostate Cancer Clinical Trials Consortium

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Muscadine Plus Grape Skin Extract: 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.

Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg

Dose-escalation Phase 1: MPX 1000mg

Dose-escalation Phase 1: MPX 2000mg

Dose-escalation Phase 1: MPX 3000mg

Dose-escalation Phase 1: MPX 4000mg

Phase 2: Placebo Control

Phase 2: Low-dose MPX

Phase 2: High-dose MPX

Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The Eastern Cooperative Oncology Group (ECOG) scale is a measure of performance status with 0 (fully active) as the best score and 1 being restricted to physically strenuous activity.

Baseline characteristics were not collected for subjects who withdrew from the study. ECOG was not analyzed in the dose-escalation phase.

Eastern Cooperative Oncology Group (ECOG)

≤6, 3+4

≥8, 4+3

The gleason score is an indication of prognosis based on prostate pathology. The score ranges from 2 to 10 with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5).

Gleason score was recorded differently in the dose-escalation phase and phase 2.

Gleason score

Baseline PSADT was recorded as a mean in the dose-escalation phase, versus as number of participants with greater than or less than 9 months PSADT in Phase 2.

Baseline PSA doubling time (PSADT)

Baseline PSADT

Radiation

Surgery

Radiation & Surgery

Cryotherapy

Brachytherapy

Androgen Deprivation Therapy (ADT)

Participants in Phase 2 were not categorized as 'Radiation \& Surgery'. Only individual counts for each prior therapy received was recorded.

Prior therapy

Alanine/Alanine (Ala/Ala)

Alanine/Valine (Ala/Val)

Valine/Valine (Val/Val)

SOD2 genotype was not recorded in dose-escalation phase. In Phase 2, SOD2 genotype was not recorded for all participants if data was unavailable.

Superoxide dismutase 2 (SOD2) genotype

Dr. Channing Paller

(Phase I) Maximum Tolerated Dose

(Phase II) Prostate Specific Antigen Doubling Time (PSADT)

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Data was not collected for this secondary outcome measure.

(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%

Patients counted in the analysis were evaluable if they completed at least six cycles of treatment prior to discontinuation

Spots Global Cancer Trial Database for muscadine plus grape skin extract