MGE + ADT for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
It is estimated that one-third of the more than 7 million deaths from cancer worldwide are attributable to potentially modifiable risk factors, with 374,000 deaths preventable through diet modification alone. Diet supplementation for the prevention or treatment of cancer is attractive, as implementation is relatively easy, even in populations with reduced incomes and resources. Grape extracts or active components isolated from grapes have received attention as chemopreventive or therapeutic agents based upon their anti-proliferative, anti-inflammatory, and anti-oxidant properties. Evidence from preclinical trials also suggests that muscadine grape products may decrease systemic inflammation. This study builds upon promising preclinical and clinical evidence to determine if the addition muscadine grape extract (MGE) to androgen deprivation therapy (ADT) improves symptoms in men with prostate cancer.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must continue androgen deprivation therapy (ADT) if you are already on it. It's best to discuss your specific medications with the trial team.
Is the treatment MGE + ADT for prostate cancer safe?
How does the MGE + ADT treatment for prostate cancer differ from other treatments?
The MGE + ADT treatment for prostate cancer is unique because it combines androgen deprivation therapy (ADT), which reduces male hormone levels, with megestrol acetate and low-dose estrogen, offering a potential low-cost alternative to traditional hormone therapies with a potentially better side-effect profile.678910
What data supports the effectiveness of the treatment MGE + ADT for prostate cancer?
Research shows that androgen deprivation therapy (ADT) can enhance the immune system's ability to recognize and attack prostate cancer cells, especially when combined with other treatments like vaccines. This suggests that combining ADT with other therapies may improve its effectiveness against prostate cancer.611121314
Who Is on the Research Team?
Heidi Klepin, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for English-speaking men over 18 with prostate cancer who are on androgen deprivation therapy (ADT) and expected to continue it for the next year. They must have normal organ function, be able to walk, cooperate with study activities, use contraception, and sign a consent form. Men with symptomatic metastatic disease, recent surgery or radiation, rising PSA levels while on current therapy, plans to stop ADT or start chemotherapy within a year can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive muscadine grape extract or placebo orally twice daily for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADT
- MGE
- Placebo
ADT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor