Muscadine Plus (MPX) In Men With Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Greater Washington Community Foundation

Criteria

Inclusion Criteria:

Patients meeting the following conditions are eligible for registration and participation in the study:

1. Subject has histologically or cytologically confirmed adenocarcinoma of the prostate

2. 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. 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.

3. 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:

1. All PSA values used in the calculation should be ≥ 0.20 ng/ml and overall should follow a rising trend;

2. Record every available PSA drawn within the last 12 months of the most recent local PSA;

3. The minimum requirement is 3 PSA values obtained over 3 months with a minimum of 4 weeks between measurements;

4. 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;

5. 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

4. One of the following criteria must be met.

1. Absolute level of PSA >0.4 ng/mL following surgery. (surgery only)

2. Absolute level of PSA >0.4 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, surgery + cryotherapy, etc.).

3. 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)

5. Subject is >18 years of age.

6. Subject has life expectancy of greater than 12 months.

7. Subject has Eastern Cooperative Oncology Group performance status 0, 1 or 2

8. Subject has testosterone level of ≥1.5 ng/mL at screening.

9. Subject has normal organ and marrow function as defined below:

1. Leukocytes >3,000/microliter

2. absolute neutrophil count >1,500/microliter

3. platelets >100,000/microliter

4. total bilirubin <1.5 x upper limit of normal except for Gilberts <2.5 x upper limit of normal

5. aspartate aminotransferase/Alanine transaminase ≤ 2.5 X upper limit of normal

6. creatinine ≤ 2.5 upper limit of normal

10. Subject agrees to abstain from other commercially available MuscadinePlus (MP) products (Vinetra, MuscadinePlus or MP capsules) while participating in this study.

11. 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.

12. Subject has signed a written informed consent document and agrees to comply with requirements of the study.

13. CT or MRI chest/abdomen/pelvis and bone scan without evidence of metastatic disease as an inclusion.

14. 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:

1. 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.

2. 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.

3. 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.

4. Subject has consumed any Muscadine Plus over the past 2 months.

5. Subject has a known allergy to muscadine grapes, ellagic acid or rice

6. 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.

7. 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