Prostate CancerNCT03087903
A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA
A study testing Grape Seed Extract in people with Prostate Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Grape Seed Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2018to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent has been obtained.
- Adults > or = 18 years of age.
- Histologically confirmed prostate adenocarcinoma.
- Evidence of rising PSA, on 2 separate occasions, at least one week apart. Baseline PSA must be ≥ 0.2 ng/mL at the time of screening. Radiographic evidence of disease is not allowed.
- Patients must have sufficient PSA time points prior to enrollment (a minimum of 3 PSA levels within a six month period) to calculate a baseline PSA doubling time.
- Patients must not be on active LHRH agonist/antagonist therapy and must have testosterone level > 50 ng/dL.
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- Patients must not be on active anti-androgen therapy or 5-alpha reductase inhibitors. Patients on stable dose of 5-alpha reductase inhibitors for benign prostatic hypertrophy for at least 12 months may continue. They must withdraw from the study if this is stopped while on study.
- Patients who are candidates for local salvage therapy must have had this option pursued or discussed; and the patient must have either declined salvage therapy or was deemed not to be a candidate for salvage therapy.
- Patients who have PSA recurrence after local salvage therapy may participate in this study.
- Patients with hormone sensitive disease who received prior androgen deprivation therapy as part of primary/salvage local treatment or patients receiving intermittent androgen deprivation therapy will be allowed to participate.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate hematologic function (absolute neutrophil count [ANC]≥1,500 cells/µL; hemoglobin ≥9 g/dL, platelets ≥75,000/µL).
- Adequate renal function (serum creatinine ≤ 2X the upper limit of normal (ULN)
- Adequate hepatic function (total bilirubin ≤ 2 x upper limit of normal [ULN], alanine aminotransferase [ALT]≤ 3xULN, aspartate aminotransferase [AST]≤3 x ULN).
- Patients can continue taking what they are taking at the time they start on the study, but agree not to start any new (over the counter) herbal supplement on regular basis during study duration.
- Prior chemotherapy for prostate cancer (upfront, adjuvant, etc.) is allowed as long as it was not given for hormone-refractory disease.
Who cannot join
- Patients who are on active surveillance for untreated localized disease may not participate in this study.
- Inability to swallow gelatin capsules, or any medical condition that interferes with normal gastrointestinal absorption.
- Major surgery, radiation, or treatment with any other investigational drug within 2 weeks of study treatment.
- Documented hypersensitivity reaction to any product with GSE (see complete list in Appendix 1).
- Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
- Symptomatic prostate cancer as determined by cancer-related pain requiring narcotic pain medication.
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- History of another cancer is exclusionary unless it is believed to be likely cured or is unlikely to be fatal in the next 3 years (e.g. squamous cell carcinoma, superficial bladder cancer, chronic lymphocytic leukemia, etc).
- Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is > 2 ng/mL.
- Known allergy/intolerance to soy, phosphatidycholine or any other constituents of grape seed extract.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Poudre Valley Hospital
Fort Collins, Colorado, 80524
About this study
Official title: A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)
Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year.
Read the detailed description
Patients will take 150 mg of GSE product by mouth twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation; total oral dosage is 300 mg GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits and patients must not have a doubling of their PSA (compared to baseline) by 3 months in order to continue on study. Patients who meet criteria to continue on study will be treated until disease progression or for one year (whichever comes first).
- Conditions
- Prostate Cancer
- Being tested
- Grape Seed Extract
- Keywords
- Prostate Specific Antigen (PSA), Non-Metastatic Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed ExtractDietary supplement
Also called Leucoselect Phytosome
Patients will take 150 mg of Grape Seed Extract (GSE) product by mouth twice daily (in the form of 75 mg capsule of Leucoselect Phytosome preparation). Total oral dosage is 300 mg of GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits.
| Study group | Role | What they receive |
|---|---|---|
| 150 mg of Grape Seed Extract (GSE) | Experimental | 150 mg of GSE twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation. Receives: Dietary Supplement: Grape Seed Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with PSA response
PSA response will be defined as an increase in prostate specific antigen (PSA) doubling time (PSADT) of 30% (PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern). Patients must have a PSA level of ≥ 0.2 at study entry and should have at least three prior PSA values with dates from which to calculate a PSA doubling time.
Measured: 6 weeks and 3, 6, 9, and 12 months
Secondary outcomes (1)
The rate of change of the PSA over time (PSA velocity) for each patient
PSA velocity will be calculated as a change from the first PSA reading, standardized as PSA change per month. PSA Response will be defined as increase in PSADT of 30% (PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern). Biomarkers will be defined as proinflammatory cytokines, lipid and comprehensive metabolic panel in patient serum samples as well as, gut microbiome (measured by by high-throughput16S sequencing), plasma and stool metabolomics (after short and long-term consumption of GSE), and the effects of diet on gut microbiome.
Measured: 6 weeks and 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start18 Jan 2018
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado
- Responsible party
- Sponsor
- Investigators
- Paul Maroni, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087903
- Sponsor's protocol ID
- 16-0607.cc
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2017
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maroni P, Manalo TA, Baker H, Kessler ER, Nicklawsky A, Trevisanut V, Flaig TW, Lam ET, Moore JC, Gao D, Raina K, Agarwal R. A Phase II Trial Using Grape Seed Extract for Prostate Cancer Patients With Nonmetastatic Prostate-Specific Antigen Progression After Local Therapy. Mol Carcinog. 2026 Sep 27. doi: 10.1002/mc.70183. Online ahead of print.
PubMed 42801665
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)
- ClinicalTrials.gov ID
- NCT03087903
- Acronym / sponsor ID
- 16-0607.cc
- Conditions
- Prostate Cancer
- Keywords
- Prostate Specific Antigen (PSA), Non-Metastatic Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cancer League of Colorado
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year.
Detailed description
Patients will take 150 mg of GSE product by mouth twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation; total oral dosage is 300 mg GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits and patients must not have a doubling of their PSA (compared to baseline) by 3 months in order to continue on study. Patients who meet criteria to continue on study will be treated until disease progression or for one year (whichever comes first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 150 mg of Grape Seed Extract (GSE) | Experimental | Dietary Supplement: Grape Seed Extract150 mg of GSE twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent has been obtained.
- Adults > or = 18 years of age.
- Histologically confirmed prostate adenocarcinoma.
- Evidence of rising PSA, on 2 separate occasions, at least one week apart. Baseline PSA must be ≥ 0.2 ng/mL at the time of screening. Radiographic evidence of disease is not allowed.
- Patients must have sufficient PSA time points prior to enrollment (a minimum of 3 PSA levels within a six month period) to calculate a baseline PSA doubling time.
Key exclusion criteria (9 listed)
- Patients who are on active surveillance for untreated localized disease may not participate in this study.
- Inability to swallow gelatin capsules, or any medical condition that interferes with normal gastrointestinal absorption.
- Major surgery, radiation, or treatment with any other investigational drug within 2 weeks of study treatment.
- Documented hypersensitivity reaction to any product with GSE (see complete list in Appendix 1).
- Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
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 |
|---|---|---|
| Grape Seed ExtractAlso: Leucoselect PhytosomePatients will take 150 mg of Grape Seed Extract (GSE) product by mouth twice daily (in the form of 75 mg capsule of Leucoselect Phytosome preparation). Total oral dosage is 300 mg of GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits. | Dietary supplement | 150 mg of Grape Seed Extract (GSE) |
Primary outcome
The number of patients with PSA response
Time frame: 6 weeks and 3, 6, 9, and 12 months
PSA response will be defined as an increase in prostate specific antigen (PSA) doubling time (PSADT) of 30% (PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern). Patients must have a PSA level of ≥ 0.2 at study entry and should have at least three prior PSA values with dates from which to calculate a PSA doubling time.
1 secondary outcome
The rate of change of the PSA over time (PSA velocity) for each patient
Time frame: 6 weeks and 3, 6, 9, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 42801665Maroni P, Manalo TA, Baker H, Kessler ER, Nicklawsky A, Trevisanut V, Flaig TW, Lam ET, Moore JC, Gao D, Raina K, Agarwal R. A Phase II Trial Using Grape Seed Extract for Prostate Cancer Patients With Nonmetastatic Prostate-Specific Antigen Progression After Local Therapy. Mol Carcinog. 2026 Sep 27. doi: 10.1002/mc.70183. Online ahead of print.
- 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.
Paul Maroni, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape Seed Extract in people with Prostate Cancer, run by University of Colorado, Denver 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 16 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 25 Mar 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients with PSA response (time frame: 6 weeks and 3, 6, 9, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03087903, which also lists 1 linked publication.
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 25 Mar 2025.