Grape Seed Extract for Prostate Cancer

No longer recruiting at 1 trial location

Overseen By Sarah Ballard

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: LHRH agonists, Anti-androgens

Disqualifiers: HIV, Viral hepatitis, Other cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of grape seed extract (GSE) for individuals with prostate cancer. Participants will take 150 mg of GSE twice daily, and researchers will monitor their progress regularly over a year. The trial seeks individuals with prostate cancer who have experienced rising PSA levels (a marker for prostate health) on at least two occasions. Eligible participants should not be on certain prostate cancer treatments but may have previously received specific therapies. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of GSE for prostate cancer.

Will I have to stop taking my current medications?

You can continue taking your current medications when you start the study, but you should not start any new herbal supplements during the study.

Is there any evidence suggesting that Grape Seed Extract is likely to be safe for humans?

Research has shown that grape seed extract (GSE) is generally safe for use. Studies have found that taking 300 to 800 mg per day is usually well tolerated for 8 to 16 weeks, meaning most people do not experience serious side effects within these amounts and timeframes. The specific GSE used in this trial, Leucoselect Phytosome, has been studied for its potential benefits. Although limited safety data exists for this exact product in humans, lab and animal studies suggest it has promising properties.

However, precautions are necessary. Pregnant or breastfeeding individuals should avoid GSE. Overall, existing research supports that GSE is well-tolerated, especially at the doses used in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for prostate cancer that often rely on hormone therapy, surgery, or radiation, grape seed extract (GSE) offers a natural alternative. Researchers are excited about GSE because it contains powerful antioxidants that might help inhibit cancer cell growth. This plant-based treatment is promising because it's derived from grape seeds, which are known for their health benefits, offering a potentially less invasive option with fewer side effects.

What evidence suggests that grape seed extract might be an effective treatment for prostate cancer?

Research has shown that grape seed extract (GSE) might help slow prostate cancer. In one study, patients taking GSE experienced a longer time before their prostate-specific antigen (PSA) levels doubled, increasing from an average of 5.71 months to 6.86 months. PSA is a marker used to track prostate cancer. Another study found that GSE significantly reduced tumor growth by 59-73%. This trial will evaluate the effects of 150 mg of GSE, taken twice daily, on prostate cancer. These findings suggest that GSE could be a promising option for managing prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul D. Maroni

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults over 18 with prostate cancer who've seen a rise in PSA after local therapy, not on active hormone therapies, and have declined or aren't candidates for salvage therapy. They must be able to swallow capsules, have no severe allergies to GSE products, and not be on surveillance for untreated localized disease.

Inclusion Criteria

I am able to care for myself and perform daily activities.

My prostate cancer was confirmed through a tissue examination.

My PSA levels have increased on two tests done a week apart, with a baseline of at least 0.2 ng/mL, and I have no visible cancer on scans.

Exclusion Criteria

My PSA levels are rising very quickly.

I cannot swallow pills or have a condition affecting my stomach's ability to absorb medicine.

I am not just being watched for my untreated localized disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 150 mg of GSE product by mouth twice daily for one year

12 months

Every 6 weeks for 3 months, then every 3 months thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Grape Seed Extract

Trial Overview The study tests the effects of Grape Seed Extract (GSE) taken orally at 150 mg twice daily. Participants will take GSE for up to one year with evaluations every six weeks initially and then every three months.

How Is the Trial Designed?

Group I: 150 mg of Grape Seed Extract (GSE) Experimental Treatment 1 Intervention

150 mg of GSE twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Cancer League of Colorado

Collaborator

Trials

13

Recruited

450+

Published Research Related to This Trial

Grape seed extract (GSE) induces significant morphological changes in prostate cancer PC-3 cells, including cell shrinkage and membrane damage, indicating its potential effectiveness in cancer treatment.

The study demonstrated that GSE can lead to necrosis and apoptosis in PC-3 cells after 24, 48, and 72 hours of treatment, suggesting it may be a promising natural therapeutic agent against prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Grape seed extract induces morphological changes of prostate cancer PC-3 cells]. Shang, XJ., Yin, HL., Ge, JP., et al.[2009]

Grape seed extract (GSE) effectively inhibits the growth of prostate cancer PC-3 cells in a concentration- and time-dependent manner, suggesting its potential as a treatment for prostate cancer.

In contrast, GSE showed only a mild inhibitory effect on normal kidney cells, indicating a degree of safety for normal tissues while targeting cancer cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Grape seed extract inhibits the growth of prostate cancer PC-3 cells]. Huang, TT., Shang, XJ., Yao, GH., et al.[2008]

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT219/761882/Abstract-CT219-Phase-II-trial-of-grape-seed

Phase II trial of grape seed extract for localized prostate ... In conclusion, GSE may delay progression of prostate cancer based on impact of PSADT; PCa patients with increased baseline PSA and testosterone ...

2. news.cuanschutz.edu news.cuanschutz.edu/cancer-center/maroni-prostate-grape-seed-extract

Can Grape Seed Extract Slow the Growth of Prostate ... The study found that PSA doubling time for the men taking the grape seed extract increased on average from 5.71 months to 6.86 months. About 78% ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14696100/

Grape seed extract inhibits advanced human prostate tumor ... Our data show that GSE feeding strongly inhibited tumor growth that accounted for 59-73% (p < 0.001) inhibition in tumor volume and 37-47% (p < 0.05) decrease ...

4. aacrjournals.org aacrjournals.org/cancerres/article/80/16_Supplement/CT207/645207/Abstract-CT207-A-phase-II-trial-using-grape-seed

A phase II trial using grape seed extract for prostate cancer ... These results indicate that 300mg of daily GSE may improve PSA kinetics in pts with a rising PSA after maximum local therapy.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03087903?intr=%22Grape%20Seed%20Extract%22&viewType=Table&rank=7

A Study of Grape Seed Extract in Asymptomatic Non- ... Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

6. withpower.com withpower.com/trial/phase-prostatic-neoplasms-2018-dea4b

Grape Seed Extract for Prostate Cancer · Info for Participants The research articles focus on the effects of grape seed extract on prostate cancer cells and animal models, but they do not provide specific safety data for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8225569/

LEUCOSELECT PHYTOSOME MODULATES SERUM ... Grape seed procyanidin extract (GSE) has been shown to exert antineoplastic properties in preclinical studies. Recently we reported findings from a modified ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04515004

Study Details | NCT04515004 | Leucoselect Phytosome for ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... A standardized grape seed procyanidin extract complexed with soy phospholipid.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2667031324000186

Recent advances in phytosomes for the safe management ... Phytosomes are promising carriers to deliver anticancer PCs to the target site with improved bioavailability and stability owing to their unique properties.

10. healthline.com healthline.com/nutrition/grape-seed-extract-benefits

10 Benefits of Grape Seed Extract, Based on Science Dosages of around 300–800 mg per day for 8–16 weeks have been found to be safe and well tolerated in humans. Those who are pregnant or breastfeeding should ...