Prostate CancerPhase 1/2NCT01317199
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 study testing Muscadine Plus Grape Skin Extract, Low-dose MPX and High-dose MPX in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Muscadine Plus Grape Skin Extract, Low-dose MPX and High-dose MPX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2011to Nov 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Karmanos Cancer Institute
Detroit, Michigan, 48201
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Howard University College of Medicine
Washington D.C., District of Columbia, 20060
About this study
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
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
- Prostate Cancer
- Being tested
- Muscadine Plus Grape Skin Extract, Low-dose MPX, High-dose MPX, Placebo oral capsule
- Keywords
- Rising psa
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscadine Plus Grape Skin ExtractDrug
Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle
Low-dose MPXDrug
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 MPXDrug
Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Placebo oral capsuleDrug
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Muscadine Plus Grape Skin Extract |
| 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). Receives: Drug: Placebo oral capsule |
| Phase 2: Low-dose MPX | Experimental | Randomly-assigned participants receive low-dose (500mg) MPX Receives: Drug: Low-dose MPX |
| Phase 2: High-dose MPX | Experimental | Randomly-assigned participants receive high-dose (4000mg) MPX Receives: Drug: High-dose MPX |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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.
Measured: 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.
Measured: Change from baseline to month 12
Secondary outcomes (3)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events reported verbally by patient and documented in study notes.
Measured: At month 12 post-intervention
(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%
Measured: 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
Measured: At month 12 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-dose
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Howard University, Prostate Cancer Clinical Trials Consortium
- Responsible party
- Sponsor
- Investigators
- Michael A Carducci, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317199
- Sponsor's protocol ID
- J1161
- Status last verified
- Jun 2018
- First submitted
- 11 Mar 2011
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01317199
- Acronym / sponsor ID
- J1161
- Conditions
- Prostate Cancer
- Keywords
- Rising psa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Howard University, Prostate Cancer Clinical Trials Consortium
- Study start
- Jul 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Posted 18 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Arm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-dose
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract | Experimental | Drug: Muscadine Plus Grape Skin ExtractMuscadine 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 | Drug: Placebo oral capsuleRandomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). |
| Phase 2: Low-dose MPX | Experimental | Drug: Low-dose MPXRandomly-assigned participants receive low-dose (500mg) MPX |
| Phase 2: High-dose MPX | Experimental | Drug: High-dose MPXRandomly-assigned participants receive high-dose (4000mg) MPX |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscadine Plus Grape Skin ExtractPhase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle | Drug | Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract |
| Low-dose MPXRandomly-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). | Drug | Phase 2: Low-dose MPX |
| High-dose MPXRandomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). | Drug | Phase 2: High-dose MPX |
| Placebo oral capsuleRandomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). | Drug | Phase 2: Placebo control |
Primary outcome
(Phase I) Maximum Tolerated Dose
Time frame: Up to 7 months post-intervention
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.
(Phase II) Prostate Specific Antigen Doubling Time (PSADT)
Time frame: Change from baseline to month 12
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.
3 secondary outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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
Time frame: At month 12 post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Carducci, MD principal investigator
Johns Hopkins University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Muscadine Plus Grape Skin Extract, Low-dose MPX and High-dose MPX in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Phase I) Maximum Tolerated Dose (time frame: Up to 7 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.