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| Name | Class |
|---|---|
| Howard University | OTHER |
| Prostate Cancer Clinical Trials Consortium | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract | Experimental | 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. |
|
| Phase 2: Placebo control | Placebo Comparator | Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). |
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| Phase 2: Low-dose MPX | Experimental | Randomly-assigned participants receive low-dose (500mg) MPX |
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| Phase 2: High-dose MPX | Experimental | Randomly-assigned participants receive high-dose (4000mg) MPX |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscadine Plus Grape Skin Extract | Drug | Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| (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 |
| (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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Carducci, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| Howard University College of Medicine |
Enrolled subjects agreed to abstain from other commercially available Muscadine Plus products while in this trial.
If subjects were taking other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, etc) prior to study entry, they had to be on a stable dose for 2 months prior and not stop while on trial.
Recruitment dates:
Phase I: October 4, 2011-August 7, 2012 in medical clinics Phase II: January 31, 2013-October 20, 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose-escalation Phase 1 |
|
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Arm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-dose
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Phase 1 (Arms 1) - open label Phase 2 (Arms 2-4) - randomized, double-blind
| Low-dose MPX | Drug | 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). |
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| High-dose MPX | Drug | Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). |
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| Placebo oral capsule | Drug | Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). |
|
| At month 12 post-intervention |
| (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 |
| Washington D.C. |
| District of Columbia |
| 20060 |
| United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| FG001 | Phase 2: Placebo Control | Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). |
| FG002 | Phase 2: 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). |
| FG003 | Phase 2: High-dose MPX | Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). |
| Cycle 1: 500mg MPX Once Daily for 28 Day |
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| Cycle 2: 1000mg MPX Daily for 28 Days |
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| Cycle 3: 2000mg MPX Daily for 28 Days |
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| Cycle 4: 3000mg MPX Daily for 28 Days |
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| Cycle 5: 4000mg MPX Daily for 28 Days |
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| COMPLETED |
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| NOT COMPLETED |
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| Randomized Phase 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) | 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. |
| BG001 | Phase 2: Placebo Control | Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). |
| BG002 | Phase 2: 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). |
| BG003 | Phase 2: High-dose MPX | Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Eastern Cooperative Oncology Group (ECOG) | 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. | Count of Participants | Participants |
| |||||||||
| Gleason score | 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. | Count of Participants | Participants |
| |||||||||
| Baseline PSA doubling time (PSADT) | 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. | Mean | Standard Deviation | months |
| |||||||||
| Baseline PSADT | 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. | Count of Participants | Participants |
| ||||||||||
| Prior therapy | Participants in Phase 2 were not categorized as 'Radiation & Surgery'. Only individual counts for each prior therapy received was recorded. | Count of Participants | Participants |
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| Superoxide dismutase 2 (SOD2) genotype | SOD2 genotype was not recorded in dose-escalation phase. In Phase 2, SOD2 genotype was not recorded for all participants if data was unavailable. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | mg | Up to 7 months post-intervention |
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| 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. | Posted | Median | Full Range | months | Change from baseline to month 12 |
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| 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. | Posted | Count of Participants | Participants | At month 12 post-intervention |
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| Secondary | (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33% | Data was not collected for this secondary outcome measure. | Posted | At month 12 post-intervention |
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| 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 | Patients counted in the analysis were evaluable if they completed at least six cycles of treatment prior to discontinuation | Posted | Count of Participants | Participants | At month 12 post-intervention |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Dose-escalation Phase 1: MPX 1000mg | 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. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Dose-escalation Phase 1: MPX 2000mg | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Dose-escalation Phase 1: MPX 3000mg | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG004 | Dose-escalation Phase 1: MPX 4000mg | 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. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Phase 2: Placebo Control | Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). | 0 | 23 | 0 | 23 | 3 | 23 |
| EG006 | Phase 2: 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). | 0 | 55 | 1 | 55 | 10 | 55 |
| EG007 | Phase 2: High-dose MPX | Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). | 0 | 47 | 1 | 47 | 7 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | Systematic Assessment | Unrelated to study drug. |
| |
| Vocal Chord Squamous Cell Carcinoma | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to study drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | Systematic Assessment | Related to study drug |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Channing Paller | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 410-955-8239 | cpaller1@jhmi.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Withdrawal by Subject |
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| Adverse Event |
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| Comorbidities |
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| Rising PSA, not as defined by protocol |
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| Disenrolled before treatment |
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| Patient stopped taking study drug |
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| Patient transferred to other facility |
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| ≥8, 4+3 |
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| 6 |
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| 7 |
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| 8 |
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| 9 |
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| Surgery |
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| Radiation & Surgery |
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| Cryotherapy |
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| Brachytherapy |
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| Androgen Deprivation Therapy (ADT) |
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| Alanine/Valine (Ala/Val) |
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| Valine/Valine (Val/Val) |
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Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). |
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| Counts |
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| Participants |
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