Muscadine Plus (MPX) In Men With Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Dec 20, 2021
  • participants needed
    80
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 20 July 2020
Investigator
Donnie Dowling, RN
Primary Contact
Chesapeake Urology Research Associates (9.3 mi away) Contact
+13 other location
prostatectomy
cancer
definitive treatment
testosterone
metastasis
neutrophil count
bone scan
prostate specific antigen
testosterone level
brachytherapy
prostate tumor

Summary

This research is being done to determine if men with rising PSA after initial therapy for localized prostate cancer who display the Alanine/Alanine SOD2 genotype of MnSOD and supplement their diet with MPX have greater decrease in PSA slope following treatment compared to men that do not supplement with MPX.

Description

Prostate specific antigen (PSA) is a single-chain glycoprotein produced by the epithelial cells of the prostate. PSA has been used for early detection and monitoring of patients with prostate cancer who receive a variety of treatments. Due to the widespread use of serum PSA to monitor for prostate cancer recurrence following primary treatment, there exists a group of men with a rising PSA as their only evidence of recurrence. These patients may not demonstrate clinical or radiographic evidence of disease progression for an average 8 years from the time of detectable PSA to detectable metastatic disease by standard imaging. Currently there are limited treatment options for these patients that may delay disease progression or improve survival, including salvage radiation for prior surgical patients, hormonal therapy, and active surveillance.

Although some surgical patients are candidates for salvage radiation, not all patients will want salvage radiation. Even the early initiation of hormonal therapy (e.g., luteinizing hormone releasing hormone (LHRH) analogs) has not demonstrated a survival benefit, although Schroder et al suggests an advantage for early hormone therapy in the setting of metastatic regional lymph nodes. Furthermore, early initiation of androgen ablation is associated with significant morbidity and impact on quality of life, including fatigue, hot flashes, loss of libido, decreased muscle mass, and osteoporosis with long term use. This group of relatively well men with biochemical recurrence are currently offered androgen ablation therapy or active surveillance (regular PSA monitoring and annual scans) until there is evidence of metastatic disease, because other options have not been available. These patients are excellent candidates for innovative treatments hypothesized to slow the progression of clinical prostate cancer and delay the development of metastatic disease.

As the previous section documents, preclinical studies of muscadine grape skin offer evidence that it may extend the time between biochemical recurrence and development of metastatic disease. While the Phase II study described above found no significant difference in PSA doubling time between placebo and either dose of MPX, there was a signal of benefit in the subgroup analysis of men with the Alanine/Alanine superoxide dismutase 2 (SOD2) genotype that received high dose MPX. It is therefore proposed to test the benefits of high dose MPX in capsule formulation in a randomized, controlled study of men who have failed primary therapy, either radiation, surgery or cryotherapy, as primary treatment for prostate cancer. Eligible subjects will have a rising PSA and will have 3 PSA values at least 7 days apart with a recovered testosterone to be able to calculate a baseline PSA doubling time. The primary endpoint of this study will be mean PSA slope during the study period.

Details
Treatment placebos, Muscadine Plus
Clinical Study IdentifierNCT03535675
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on20 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Are you male?
Do you have Adenocarcinoma of the Prostate?
Patients meeting the following conditions are eligible for registration and
participation in the study
Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
Subject has undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor (prior chemotherapy is not allowed)
A subject with a rising PSA post-prostatectomy should consider radiation as a potentially curative alternative. If subject declines radiation or is not a candidate for radiation, he may be considered eligible in this setting
Subject has a rising PSA on a minimum of 3 time points (2 rises) within the 12 months prior to study initiation (this will include the PSA measurement taken at the screening visit, but not at the baseline day 0 study visit)
For purposes of calculating PSADT
All PSA values used in the calculation should be 0.20 ng/ml and overall should follow a rising trend
Record every available PSA drawn within the last 12 months of the most recent local PSA
The minimum requirement is 3 PSA values obtained over 3 months with a minimum of 4 weeks between measurements
If there are 4 or more PSAs available, the time interval between the first and last PSA measurements must be at least 3 months, and, there is no minimum time interval requirement between any two PSA measurements
For radiotherapy only patients, record PSA nadir value and collection date. PSADT must be positive according to Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms under this link: <http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx>
One of the following criteria must be met
Absolute level of PSA >0.4 ng/mL following surgery. (surgery only)
Absolute level of PSA >0.4 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, surgery + cryotherapy, etc.)
A rise by 2 ng/mL or more above the nadir PSA will be considered the standard definition for biochemical failure after radiation therapy with or without hormonal therapy. (radiation only)
Subject is >18 years of age
Subject has life expectancy of greater than 12 months
Subject has Eastern Cooperative Oncology Group performance status 0, 1 or 2
Subject has testosterone level of 1.5 ng/mL at screening
Subject has normal organ and marrow function as defined below
Leukocytes >3,000/microliter
absolute neutrophil count >1,500/microliter
platelets >100,000/microliter
total bilirubin <1.5 x upper limit of normal except for Gilberts <2.5 x upper limit of normal
aspartate aminotransferase/Alanine transaminase 2.5 X upper limit of normal
creatinine 2.5 upper limit of normal
Subject agrees to abstain from other commercially available MuscadinePlus (MP) products (Vinetra, MuscadinePlus or MP capsules) while participating in this study
Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, acai concentrated extract, 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
Subject has signed a written informed consent document and agrees to comply with requirements of the study
CT or MRI chest/abdomen/pelvis and bone scan without evidence of metastatic disease as an inclusion
Subject agrees to genotyping of manganese-dependent superoxide dismutase 2 (MnSOD2) gene and any genetic counseling. Only those with Alanine/Alanine SOD2 genotype will be randomized

Exclusion Criteria

Subjects meeting the following conditions are not eligible for participation
in the study
Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 1.5 cm maybe considered nonspecific and the patient would be eligible. If there is any clinical suspicion for metastatic disease, CT and Bone Scan must be performed to rule out metastatic disease, within the last four months, per standard of care
Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 12 months prior to study
Subject has had 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
Subject has consumed any Muscadine Plus over the past 2 months
Subject has a known allergy to muscadine grapes, ellagic acid or rice
Subject has uncontrolled concurrent 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
Subject has negative PSA doubling time (negative doubling time corresponds with decreasing PSA) Doubling time may be computed using the Sloan Kettering prediction tools posted at <http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx>
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