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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
Able to ambulate (use of assist device is acceptable)
Men age ≥18 years who are fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, and 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I can walk, even if I need a device to help me.
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I am a man, 18 or older, and speak English fluently.
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I can understand and am willing to sign the consent form.
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My prostate cancer was confirmed through a tissue examination.
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I agree to use effective birth control or remain abstinent during the study.
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My recent tests show my organs and bone marrow are functioning well.
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I am undergoing or have had treatment to lower my testosterone levels for prostate cancer.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in fatigue
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,836 Total Patients Enrolled
21 Trials studying Prostate Cancer
1,769 Patients Enrolled for Prostate Cancer
Heidi Klepin, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
141 Total Patients Enrolled

Media Library

ADT (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03496805 — Phase 2
Prostate Cancer Research Study Groups: MGE group, Placebo group
Prostate Cancer Clinical Trial 2023: ADT Highlights & Side Effects. Trial Name: NCT03496805 — Phase 2
ADT (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03496805 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients be assured that Medical Grade Ethanol is harmless?

"The safety of MGE was rated a 2, due to the lack of efficacy data but presence of previous research that suggested its security."

Answered by AI

Is there an ongoing enrollment process for this clinical research?

"This clinical trial, according to information found on clinicialtrials.gov, is currently in search of volunteers; the first posting occurred on January 29th 2019 and was most recently modified on November 2nd 2022."

Answered by AI

What is the scope of participation in this research initiative?

"Affirmative. Clinicaltrials.gov notes that this medical trial, initially posted on January 29th 2019, is still searching for patients to enroll. A total of 160 individuals are required at two separate sites."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
65+
What site did they apply to?
Wake Forest Baptist Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2024