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Hormone Therapy

MGE + ADT for Prostate Cancer

Phase 2

Recruiting

Led By Heidi Klepin, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed prostate adenocarcinoma

Be older than 18 years old

Must not have

Symptomatic metastatic disease requiring medical treatment (i.e., painful metastases to bone)

Inability to swallow oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, and 12 months

Summary

This trial is testing whether adding muscadine grape extract to androgen deprivation therapy improves symptoms in men with prostate cancer.

Who is the study for?

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.

What is being tested?

The trial tests if adding muscadine grape extract (MGE), known for its anti-inflammatory and antioxidant properties, to standard ADT improves symptoms in men with prostate cancer. Participants will either receive MGE or a placebo alongside their ongoing ADT treatment.

What are the potential side effects?

Potential side effects of MGE may include allergic reactions similar to those from compounds of like chemical structure. The study excludes individuals who have had allergic reactions attributed to such compounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer was confirmed through a tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have painful cancer spread that needs treatment.

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I cannot swallow pills.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have severe digestion issues causing uncontrolled symptoms despite daily treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in fatigue

Secondary study objectives

Changes in body composition

Changes in cognitive abilities

Changes in physical performance

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MGE groupExperimental Treatment2 Interventions

Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.

Group II: Placebo groupPlacebo Group2 Interventions

Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo.

0 / 5Eligibility criteria met