Grape Seed Extract for Prostate Cancer

Recruiting at 1 trial location

Overseen By Sarah Ballard

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Colorado, Denver

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

41 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves patients taking a grape seed extract supplement to help manage their prostate health. The supplement is believed to protect cells and reduce inflammation. Patients' PSA levels will be monitored to assess the effectiveness of the treatment.

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.

What evidence supports the effectiveness of the treatment Grape Seed Extract for prostate cancer?

Research shows that grape seed extract can significantly slow down the growth of prostate tumors in mice and human prostate cancer cells. It also helps reduce tumor size and prevent the formation of new blood vessels that tumors need to grow. ^{1 2 3 4 5}

Is grape seed extract safe for humans?

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 humans. However, grape seed extract is generally considered safe when consumed in moderate amounts, as it is a common dietary supplement. ^{1 2 3 4 5}

How does the treatment Grape Seed Extract differ from other prostate cancer treatments?

Grape Seed Extract is unique because it is a natural supplement that may help prevent and slow the growth of prostate cancer by inducing cell death and inhibiting tumor growth, unlike traditional treatments that often involve surgery, radiation, or hormone therapy. It works by causing cancer cells to detach and die, a process known as anoikis, and by activating certain proteins that lead to cell death. ^{1 2 3 4 5}

Research Team

Paul D. Maroni

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral grape seed extract inhibits prostate tumor growth and progression in TRAMP mice. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Grape seed extract inhibits advanced human prostate tumor growth and angiogenesis and upregulates insulin-like growth factor binding protein-3. [2016]

3. China pubmed.ncbi.nlm.nih.gov

[Grape seed extract inhibits the growth of prostate cancer PC-3 cells]. [2008]

4. China pubmed.ncbi.nlm.nih.gov

[Grape seed extract induces morphological changes of prostate cancer PC-3 cells]. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Grape seed extract induces anoikis and caspase-mediated apoptosis in human prostate carcinoma LNCaP cells: possible role of ataxia telangiectasia mutated-p53 activation. [2021]