Green Tea for Prostate Cancer

Recruiting at 329 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: ECOG-ACRIN Cancer Research Group

Must not be taking: Hormone therapy, Chemotherapy

Disqualifiers: Renal disease, Hepatic disease, Metastases, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must stop using your current vitamin/mineral supplements and use the ones provided by the study.

What evidence supports the effectiveness of the treatment Green Tea for prostate cancer?

Research suggests that green tea, particularly its polyphenols like epigallocatechin gallate (EGCG), may help prevent prostate cancer by affecting cancer cell growth and signaling pathways. Clinical trials and studies in animals and cells have shown promising results, although more research is needed to confirm these effects in humans. ^{1 2 3 4 5}

Is green tea safe for use in humans, particularly for prostate cancer prevention?

Clinical trials and studies suggest that green tea and its components, like epigallocatechin gallate (EGCG), are generally safe for human use, with no significant adverse effects reported in trials for prostate cancer prevention. ^{1 2 6 7 8}

How does green tea treatment differ from other prostate cancer treatments?

Green tea treatment is unique because it uses natural polyphenols, particularly epigallocatechin gallate (EGCG), which have shown potential in preventing and slowing the growth of prostate cancer cells by affecting various cellular pathways. Unlike conventional treatments, green tea offers a dietary approach that may inhibit cancer cell growth without significantly impacting normal cells. ^{1 2 3 5 9}

Research Team

Nagi B Kumar

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

Men with low to intermediate-risk prostate cancer under active surveillance can join. They must have a recent biopsy showing adenocarcinoma, be in good physical condition (ECOG 0-1), and agree to stop taking their own supplements for the study's version. HIV-positive men on effective treatment are eligible. Participants need normal organ function tests, agree to limit tea intake, use contraception if sexually active, and commit to follow-up biopsies.

Inclusion Criteria

Patient must have a serum PSA < 10 ng/mL or PSAD < 0.15 ng/mL/ g obtained within 30 days of registration

Patient must be willing to restrict tea consumption to less than three servings of hot tea or iced tea per week

I am following a watchful waiting plan for my cancer, as recommended.

Exclusion Criteria

I have not received any treatment for prostate cancer before.

I have no history of kidney or liver diseases, including hepatitis B or C.

Patient must not receive any other investigational agents while on this study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive green tea catechins or placebo orally twice daily for up to 6 months

6 months

Monthly visits for monitoring and pill counts

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

Follow-up visits at approximately 7 days, 6 months, and up to 12 months

Treatment Details

Interventions

• Green Tea (Cancer Preventive Agent)

Trial Overview This phase II trial is testing whether green tea catechins can prevent prostate cancer from advancing in stages among men who are monitoring their condition without immediate treatment. The study involves taking either the green tea extract or a placebo and completing questionnaires about quality of life.

Participant Groups

Group I: Arm A (green tea catechins) Experimental Treatment 3 Interventions

Patients receive green tea catechins PO BID for up to 6 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (placebo) Placebo Group 3 Interventions

Patients receive placebo PO BID for up to 6 months.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Green tea polyphenols (GTP), particularly epigallocatechin-3-gallate (EGCG), have shown promising effects in preventing and treating prostate cancer (PCa) by inhibiting cancer cell growth while sparing normal cells.

The review highlights that both in vitro and in vivo studies, as well as human clinical trials, support the cancer-preventive properties of GTP and EGCG, suggesting their potential as dietary agents in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of signaling pathways in prostate cancer by green tea polyphenols. Khan, N., Mukhtar, H.[2022]

Green tea, particularly its main component epigallocatechin gallate (EGCG), has shown promising anticancer effects in laboratory and animal studies, suggesting its potential as a natural cancer preventive and therapeutic agent.

Clinical trials involving green tea polyphenols (GTP) have produced encouraging results, especially in prostate cancer patients, indicating that these findings may be relevant for human health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multitargeted therapy of cancer by green tea polyphenols. Khan, N., Mukhtar, H.[2022]

Green tea (GT) contains higher levels of monomeric polyphenols that are better absorbed and have been shown to have a strong chemopreventive effect against prostate cancer, supported by various in vitro, in vivo, and clinical studies.

Black tea (BT) has weaker evidence for chemoprevention of prostate cancer, although some animal studies suggest it may inhibit cancer growth, indicating that while GT is more effective, BT still has potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemopreventive effects of tea in prostate cancer: green tea versus black tea. Henning, SM., Wang, P., Heber, D.[2021]

In a randomized trial involving men with prostate cancer, daily administration of polyphenon E (green tea polyphenol extract) for 3 to 6 weeks showed low bioavailability in prostate tissue, indicating that the polyphenols did not accumulate effectively in the target area.

Although there were favorable trends in biomarkers related to prostate cancer, such as serum prostate-specific antigen and oxidative DNA damage, these changes were not statistically significant, suggesting that the potential preventive effects of green tea polyphenols may require longer treatment durations or earlier intervention in the disease process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. Nguyen, MM., Ahmann, FR., Nagle, RB., et al.[2022]

Green tea, particularly its catechins, may help prevent prostate cancer, which is notably prevalent in affluent countries, based on a review of various studies.

While epidemiological evidence is still developing, animal and in vitro studies support the idea that green tea consumption is linked to a reduced risk or slower progression of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effects of green tea against prostate cancer. Lee, AH., Fraser, ML., Meng, X., et al.[2022]

In a randomized clinical trial involving 97 men with high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP), daily intake of 400 mg of green tea catechins (Polyphenon E) did not significantly reduce the overall incidence of prostate cancer compared to placebo.

However, the study found a significant reduction in the diagnosis of ASAP among men taking Polyphenon E, with no cases reported in the treatment group versus 5 cases in the placebo group, suggesting a potential benefit in preventing this specific condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention. Kumar, NB., Pow-Sang, J., Egan, KM., et al.[2022]

(-)-Epigallocatechin-3-gallate (EGCG), a component of green tea, was identified as the most effective agent in inhibiting the growth of prostate cancer cell lines (LNCaP, PC-3, and DU145).

EGCG induces cell death through apoptosis, as evidenced by changes in nuclear morphology and DNA fragmentation, highlighting its potential as an anticancer agent for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of apoptosis in prostate cancer cell lines by the green tea component, (-)-epigallocatechin-3-gallate. Paschka, AG., Butler, R., Young, CY.[2022]

Green tea, particularly its main component epigallocatechin-3-gallate (EGCG), has shown potential protective effects against prostate cancer through various biological mechanisms, including promoting cell death and inhibiting cancer-related pathways.

Despite some promising preclinical findings, there is currently no proven benefit of green tea polyphenol supplementation in preventing genitourinary cancers, largely due to issues with bioavailability and low concentrations in target tissues, indicating a need for further research and improved formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green tea polyphenols and cancer chemoprevention of genitourinary cancer. Bailey, HH., Mukhtar, H.[2020]

Intraperitoneal injection of green tea's active compound, (-)epigallocatechin-3-gallate, significantly inhibited the growth of prostate tumors in mice, suggesting its potential as a therapeutic agent against prostate cancer.

The same compound also reduced tumor growth in breast cancer models, indicating a broader anti-cancer effect, which may explain the lower cancer rates observed in populations with high green tea consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth inhibition and regression of human prostate and breast tumors in athymic mice by tea epigallocatechin gallate. Liao, S., Umekita, Y., Guo, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Modulation of signaling pathways in prostate cancer by green tea polyphenols. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Multitargeted therapy of cancer by green tea polyphenols. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Chemopreventive effects of tea in prostate cancer: green tea versus black tea. [2021]

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

Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Protective effects of green tea against prostate cancer. [2022]

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

Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Induction of apoptosis in prostate cancer cell lines by the green tea component, (-)-epigallocatechin-3-gallate. [2022]

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

Green tea polyphenols and cancer chemoprevention of genitourinary cancer. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Growth inhibition and regression of human prostate and breast tumors in athymic mice by tea epigallocatechin gallate. [2022]