Recurrent Prostate CancerPhase 2NCT03496805
Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
A Phase 2 study testing MGE and ADT in people with Recurrent Prostate Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recurrent Prostate Cancer
- What is being tested?
- MGE and ADT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2019to 14 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age ≥18 years who are fluent in English.
- Histologically confirmed prostate adenocarcinoma.
- Prior surgical castration or active ongoing use of androgen deprivation therapy (ADT) with expectation by the treating physician that patient would remain on ADT for the upcoming 12 months. ADT in the setting of definitive radiation therapy permitted. Concurrent treatment with androgen pathway inhibitors (examples include enzalutamide, abiraterone, darolutamide, apalutamide) permitted..
- Normal organ and marrow function function (labs within 30 days prior to study entry) as defined below:
- White blood cell count greater than or equal to 3,500/mcL (or 3.5 (x103)) Platelet count greater than or equal to 75,000/mcL (or 75 (x103)) Hemoglobin greater than or equal to >9 g/dL Total bilirubin less than or equal to 2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal Creatinine less than or equal to 2.5 X institutional upper limit of normal
- Able to ambulate (use of assist device is acceptable).
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- Able to cooperate with study-related activities.
- The effects of MGE on the developing human fetus are unknown. Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Who cannot join
- Symptomatic metastatic disease requiring medical treatment (i.e., painful metastases to bone).
- Prostate cancer related surgery or radiation within 60 days prior to study entry.
- Documented rise in PSA (defined as rise of > 0.5 ng/mL) while on current prostate cancer therapy, determined by PSA values, at least one of which must be during the 6 months prior to study entry PSA values must be at least 7 days apart.
- Planned cessation of ADT or planned use of cytotoxic chemotherapy (i.e., docetaxel) within 12 months after study entry.
- Ongoing use of any other investigational cancer-directed agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MGE.
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- Inability to swallow oral medications.
- Malabsorption due to bowel resection or gastrointestinal disease leading to uncontrolled diarrhea, or persistent nausea or vomiting requiring daily antiemetic therapy for symptom management within the past week.
- Uncontrolled intercurrent 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WG Hefner VA Medical Center
Salisbury, North Carolina, 28144
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
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.
Read the detailed description
Primary Objective: To compare levels of fatigue in the MGE group compared to the placebo group at 6 months.
Secondary Objectives
- To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and 12 months.
- To compare quality of life in men in the MGE group compared to the placebo group.
- To compare physical function, physical fitness, and body composition in men in the MGE group compared to the placebo group.
- To compare time to PSA progression (from study entry) in men in the MGE group compared to the placebo group.
- To compare progression-free survival (from study entry) in men in the MGE group compared to the placebo group.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (Muscadine grape extract): Participants begin Androgen deprivation therapy prior to receiving muscadine grape extract and then receive muscadine grape extract orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity.
GROUP II (PLACEBO): Participants begin Androgen deprivation therapy prior to receiving placebo and then receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 72 hours and then for up to 12 months.
- Conditions
- Recurrent Prostate Cancer
- Being tested
- MGE, Placebo, ADT
- Keywords
- Muscadine Grape Extract, Androgen Deprivation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGEDrug
The patients will take 4 capsules by mouth BID (twice daily).
PlaceboOther
The patients will take 4 capsules by mouth BID (twice daily).
ADTOther
Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.
| Study group | Role | What they receive |
|---|---|---|
| MGE group | Experimental | 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. Receives: Drug: MGE; Other: ADT |
| Placebo group | Placebo comparator | 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. Receives: Other: Placebo; Other: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fatigue
The PROMIS Fatigue 7a Short-Form assesses the experience (3 items) and impact (4 items) of fatigue. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric. Higher scores indicate more fatigue. Recommendations for classifying fatigue based on the T scores are as follows: <50 normal; 50-59 mild; 60-69 moderate; ≥70 severe. 50 indicates the population mean with a standard deviation of 10
Measured: 6 months
Secondary outcomes (10)
Changes in Quality of Life: PROMIS
General Quality of Life will be measured using the Patient Reported Outcomes Measurement Information System© (PROMIS©) Global Health Short Form (SF), a 10-item instrument representing multiple domains. Items assess self-reported measures of general aspects of physical, mental and social health in adults. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better general health than the general population.
Measured: Baseline and 6 months
Changes in Quality of Life: HFRDIS
Quality of life will be assessed by the Hot Flash Related Daily Interference Scale (HFRDIS). HFRDIS is a 10-item scale that assesses the degree to which hot flashes interfere with a variety of daily activities and quality of life. Interference is rated on an 11-point scale (0=not interfere; 10=completely interfere). Higher scores indicate more interference.
Measured: Baseline and 6 months
Changes in Sleep Disturbance
Sleep disturbance will be measured using the PROMIS Sleep Disturbance (SD) SF 8a. The PROMIS-SD items assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each question has five response options ranging in value from one to five. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted to a standardized T-score. Higher scores indicate more sleep disturbance.
Measured: Baseline and 6 months
Changes in Cognitive Abilities
Cognitive abilities will be measured using the PROMIS Cognitive Abilities SF 4a, which assesses patient-perceived functional abilities related to mental acuity, concentration, and memory. Raw scores are converted to a standardized T-score; final scores are represented by the T-score. Higher scored indicate more cognitive ability.
Measured: Baseline and 6 months
Changes in Self-reported Physical Function
Self-reported physical function will be measured using the PROMIS Physical Function 10a SF, which is designed to assess self-reported capability rather than actual performance of physical activities. The form consists of 10 items. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better physical function general health than the general population.
Measured: Baseline and 6 months
Changes in Physical Performance
Physical performance will be objectively assessed using the Short Physical Performance Battery (SPPB). Each performance measure is scored ranging from 0-4 (0 = unable to complete; 4 = highest performance level), with total sum score range from 0-12. Lower score on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer.
Measured: Baseline and 6 months
Changes in Sub-maximal Exercise
Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness.
Measured: baseline and 6 month
Changes in Body Composition
Whole body lean mass, fat mass, and bone mass will be measured by duel energy X-ray absorptiometry (DXA). BMI will be calculated from height and weight.
Measured: Baseline and 6 months
Changes in Prostate-specific Antigen (PSA) Progression
PSA will be measured at baseline, 6, and 12 months while patient is on MGE/placebo.
Measured: baseline, 6, and 12 months
Progression-free Survival
Progression-free survival is defined as the time from initiation of ADT treatment to disease progression or death.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start29 Jan 2019
- Primary completion20 Feb 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Klepin, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496805
- Sponsor's protocol ID
- IRB00047840
- Other IDs
- CCCWFU 85417
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2018
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT03496805
- Acronym / sponsor ID
- IRB00047840
- Conditions
- Recurrent Prostate Cancer
- Keywords
- Muscadine Grape Extract, Androgen Deprivation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective: To compare levels of fatigue in the MGE group compared to the placebo group at 6 months.
Secondary Objectives
- To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and 12 months.
- To compare quality of life in men in the MGE group compared to the placebo group.
- To compare physical function, physical fitness, and body composition in men in the MGE group compared to the placebo group.
- To compare time to PSA progression (from study entry) in men in the MGE group compared to the placebo group.
- To compare progression-free survival (from study entry) in men in the MGE group compared to the placebo group.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (Muscadine grape extract): Participants begin Androgen deprivation therapy prior to receiving muscadine grape extract and then receive muscadine grape extract orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity.
GROUP II (PLACEBO): Participants begin Androgen deprivation therapy prior to receiving placebo and then receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 72 hours and then for up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGE group | Experimental | Drug: MGE, Other: ADTPatients 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. |
| Placebo group | Placebo comparator | Other: Placebo, Other: ADTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men age ≥18 years who are fluent in English.
- Histologically confirmed prostate adenocarcinoma.
- Prior surgical castration or active ongoing use of androgen deprivation therapy (ADT) with expectation by the treating physician that patient would remain on ADT for the upcoming 12 months. ADT in the setting of definitive radiation therapy permitted. Concurrent treatment with androgen pathway inhibitors (examples include enzalutamide, abiraterone, darolutamide, apalutamide) permitted..
- Normal organ and marrow function function (labs within 30 days prior to study entry) as defined below:
- White blood cell count greater than or equal to 3,500/mcL (or 3.5 (x103)) Platelet count greater than or equal to 75,000/mcL (or 75 (x103)) Hemoglobin greater than or equal to >9 g/dL Total bilirubin less than or equal to 2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal Creatinine less than or equal to 2.5 X institutional upper limit of normal
Key exclusion criteria (9 listed)
- Symptomatic metastatic disease requiring medical treatment (i.e., painful metastases to bone).
- Prostate cancer related surgery or radiation within 60 days prior to study entry.
- Documented rise in PSA (defined as rise of > 0.5 ng/mL) while on current prostate cancer therapy, determined by PSA values, at least one of which must be during the 6 months prior to study entry PSA values must be at least 7 days apart.
- Planned cessation of ADT or planned use of cytotoxic chemotherapy (i.e., docetaxel) within 12 months after study entry.
- Ongoing use of any other investigational cancer-directed agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGEThe patients will take 4 capsules by mouth BID (twice daily). | Drug | MGE group |
| PlaceboThe patients will take 4 capsules by mouth BID (twice daily). | Other | Placebo group |
| ADTAndrogen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. | Other | MGE group, Placebo group |
Primary outcome
Changes in Fatigue
Time frame: 6 months
The PROMIS Fatigue 7a Short-Form assesses the experience (3 items) and impact (4 items) of fatigue. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric. Higher scores indicate more fatigue. Recommendations for classifying fatigue based on the T scores are as follows: <50 normal; 50-59 mild; 60-69 moderate; ≥70 severe. 50 indicates the population mean with a standard deviation of 10
10 secondary outcomes
Changes in Quality of Life: PROMIS
Time frame: Baseline and 6 months
Changes in Quality of Life: HFRDIS
Time frame: Baseline and 6 months
Changes in Sleep Disturbance
Time frame: Baseline and 6 months
Changes in Cognitive Abilities
Time frame: Baseline and 6 months
Changes in Self-reported Physical Function
Time frame: Baseline and 6 months
Changes in Physical Performance
Time frame: Baseline and 6 months
Changes in Sub-maximal Exercise
Time frame: baseline and 6 month
Changes in Body Composition
Time frame: Baseline and 6 months
Changes in Prostate-specific Antigen (PSA) Progression
Time frame: baseline, 6, and 12 months
Progression-free Survival
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Klepin, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MGE and ADT in people with Recurrent Prostate Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fatigue (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.