CompletedNCT01317199Updated Apr 2, 2021Results posted

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

A Phase 1/2 interventional study of Muscadine Plus Grape Skin Extract and Low-dose MPX in Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 143
Allocation: Randomized
Ages: 18 Years and older
Sex: Male

Study 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.

Read the 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

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,370

Keywords

Rising psa

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 143 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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

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)

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 143 participants (actual)

Study arms

Experimental
Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract
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.
Drug: Muscadine Plus Grape Skin Extract
Placebo comparator
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).
Drug: Placebo oral capsule
Experimental
Phase 2: Low-dose MPX
Randomly-assigned participants receive low-dose (500mg) MPX
Drug: Low-dose MPX
Experimental
Phase 2: High-dose MPX
Randomly-assigned participants receive high-dose (4000mg) MPX
Drug: High-dose MPX

Interventions

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

What researchers measure

Primary outcomes

(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.
Time frame: 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.
Time frame: Change from baseline to month 12

Secondary outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events reported verbally by patient and documented in study notes.
Time frame: At month 12 post-intervention
(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%
Time frame: 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
Time frame: At month 12 post-intervention

Results

Posted Jul 18, 2018

Participant flow

Recruitment dates: Phase I: October 4, 2011-August 7, 2012 in medical clinics Phase II: January 31, 2013-October 20, 2014

Dose-escalation Phase 1

Participant flow — Dose-escalation Phase 1
Milestone	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Started	14	0	0	0
Cycle 1: 500mg mpx once daily for 28 day	2	0	0	0
Cycle 2: 1000mg mpx daily for 28 days	2	0	0	0
Cycle 3: 2000mg mpx daily for 28 days	2	0	0	0
Cycle 4: 3000mg mpx daily for 28 days	2	0	0	0
Cycle 5: 4000mg mpx daily for 28 days	6	0	0	0
Completed	7	0	0	0
Not completed	7	0	0	0
Withdrew: Physician decision	5	0	0	0
Withdrew: Disease progression	1	0	0	0
Withdrew: Comorbidities, myasthenia gravis	1	0	0	0

Randomized Phase 2

Participant flow — Randomized Phase 2
Milestone	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Started	24	56	49
Completed	13	35	32
Not completed	11	21	17
Withdrew: Disease progression	3	7	5
Withdrew: Withdrawal by subject	3	5	4
Withdrew: Adverse event	0	0	1
Withdrew: Comorbidities	2	2	2
Withdrew: Rising psa, not as defined by protocol	2	5	2
Withdrew: Disenrolled before treatment	1	1	2
Withdrew: Patient stopped taking study drug	0	0	1
Withdrew: Patient transferred to other facility	0	1	0

Outcome measures

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.

Time frame:: Up to 7 months post-intervention
Reported as:: Number · mg

(Phase I) Maximum Tolerated Dose
mg	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
(Phase I) Maximum Tolerated Dose	4000	—	—	—

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.

Time frame:: Change from baseline to month 12
Reported as:: Median · months

(Phase II) Prostate Specific Antigen Doubling Time (PSADT)
months	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
(Phase II) Prostate Specific Antigen Doubling Time (PSADT)	0.9 (-6.7 to 83.1)	1.5 (-10.3 to 87.2)	0.9 (-27.3 to 88.1)

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

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

Time frame:: At month 12 post-intervention
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Participants	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	7	19	38	32

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

Time frame:: At month 12 post-intervention

No measurements were reported for this outcome.

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

Time frame:: At month 12 post-intervention
Reported as:: Count of participants · Participants

(Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline
Participants	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
(Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline	0	0	1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg	0/2 (0%)	0/2 (0%)	0/2 (0%)
Dose-escalation Phase 1: MPX 1000mg	0/2 (0%)	0/2 (0%)	1/2 (50%)
Dose-escalation Phase 1: MPX 2000mg	0/2 (0%)	0/2 (0%)	0/2 (0%)
Dose-escalation Phase 1: MPX 3000mg	0/2 (0%)	0/2 (0%)	0/2 (0%)
Dose-escalation Phase 1: MPX 4000mg	0/6 (0%)	0/6 (0%)	3/6 (50%)
Phase 2: Placebo Control	0/23 (0%)	0/23 (0%)	3/23 (13%)
Phase 2: Low-dose MPX	0/55 (0%)	1/55 (1.8%)	10/55 (18.2%)
Phase 2: High-dose MPX	0/47 (0%)	1/47 (2.1%)	7/47 (14.9%)

Most frequent serious events

Most frequent serious events
Event	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
Vocal Chord Squamous Cell CarcinomaMusculoskeletal and connective tissue disorders	0/2	0/2	0/2	0/2	0/6	0/23	0/55	1/47
CellulitisInfections and infestations	0/2	0/2	0/2	0/2	0/6	0/23	1/55	0/47

Most frequent other events

Most frequent other events
Event	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
FlatulenceGastrointestinal disorders	0/2	1/2	0/2	0/2	3/6	3/23	6/55	3/47
dyspepsiaGastrointestinal disorders	0/2	0/2	0/2	0/2	0/6	0/23	0/55	4/47
DiarrheaGastrointestinal disorders	0/2	0/2	0/2	0/2	0/6	0/23	4/55	0/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
Mean	62.6 ± 7.5	69 ± 7.1	67 ± 7.2	68 ± 6.9	67.2 ± 7.1

Sex: Female, Male
Sex: Female, Male(Participants)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
Female	0	0	0	0	0
Male	14	24	56	49	143

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	4	6	12	10	32
White	10	18	43	38	109
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	1	1	2

Region of Enrollment
Region of Enrollment(participants)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
United States	14	24	56	49	143

Eastern Cooperative Oncology Group (ECOG)
Eastern Cooperative Oncology Group (ECOG)(Participants)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
0	—	18	52	39	109
1	—	5	2	8	15

Gleason score
Gleason score(Participants)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
≤6, 3+4	—	11	25	23	59
≥8, 4+3	—	13	31	26	70
6	3	—	—	—	3
7	7	—	—	—	7
8	1	—	—	—	1
9	3	—	—	—	3

Baseline PSA doubling time (PSADT)
Baseline PSA doubling time (PSADT)(months)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
Mean	13 ± 10.1	—	—	—	13 ± 10.1

Baseline PSADT
Baseline PSADT(Participants)	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
≤9 months	—	13	32	27	72
>9 months	—	10	23	21	54

2 further baseline measures are reported on the registry.

Study locations

8 sites

Sibley Memorial Hospital
Washington, District of Columbia 20016, United States
Howard University College of Medicine
Washington, 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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01317199
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Howard University, Prostate Cancer Clinical Trials Consortium
Responsible party: Sponsor
First posted: Mar 17, 2011
Start date: Jul 2011
Primary completion: Nov 2015
Completion: Nov 2015
Results posted: Jul 18, 2018
Last update: Apr 2, 2021

Study contacts

Michael A Carducci, MD

principal investigator · Johns Hopkins University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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