Green Tea for Prostate Cancer

Recruiting at 351 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ECOG-ACRIN Cancer Research Group

Must not be taking: Hormone therapy, Chemotherapy

Disqualifiers: Renal disease, Hepatic disease, Metastases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 6 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if green tea catechins, a component of green tea, can prevent prostate cancer from worsening in men under active surveillance rather than immediate treatment. Participants will take either green tea catechins or a placebo (a pill with no active ingredients) for up to six months. Men with low-risk prostate cancer who have not yet undergone treatment and are currently on active surveillance may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that green tea catechins are likely to be safe for humans?

Research has shown that green tea might be safe for people. In past studies, individuals who drank green tea regularly had a lower chance of developing prostate cancer, suggesting that the tea is generally well-tolerated. One study found that green tea reduced the risk of prostate cancer without causing major side effects. While these results are encouraging, it is important to note that this treatment is still being tested in a phase 2 trial, so more research is needed to confirm its safety for everyone. However, current evidence suggests that green tea is a safe option for many people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard treatments for prostate cancer, which often involve hormone therapy, surgery, or radiation, the green tea catechins being studied are derived from a natural source. Researchers are excited about this treatment because green tea catechins have antioxidant properties that may inhibit cancer growth with potentially fewer side effects. Additionally, this approach offers an oral treatment option, making it easier and more convenient for patients to take regularly.

What evidence suggests that green tea might be an effective treatment for prostate cancer?

Research has shown that green tea might help lower the risk of prostate cancer. One study found that men who drank more green tea had a lower chance of developing prostate cancer. Other studies suggest that green tea can influence certain body processes related to prostate cancer development. In this trial, participants in one arm will receive green tea catechins to evaluate their potential in preventing prostate cancer growth. Previous trials indicate that green tea could be a promising way to prevent prostate cancer from worsening. ^{1 3 4 6 7}

Who Is on the Research Team?

Nagi B Kumar

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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

My prostate cancer diagnosis was confirmed with a biopsy.

I am scheduled for a prostate biopsy 6 months after starting treatment.

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

Exclusion Criteria

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

I have not received any treatment for prostate cancer before.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Green Tea

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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]

(-)-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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6340872/

Green tea extract for prevention of prostate cancer ... Green tea catechins (GTC) can modulate several relevant intermediate biological intermediate endpoint biomarkers implicated in prostate carcinogenesis as well ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2789276/

Green tea polyphenols for prostate cancer chemoprevention The data that has been collected so far suggests that green tea may be a promising agent for PCa chemoprevention and further clinical trials of participants at ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1756464620303960

A review on anti-cancer effect of green tea catechins Epidemiological studies have shown that green tea intake was associated with a moderate reduction in risk for cancers such as colorectal, stomach, esophageal ...

4. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/8/10/879/113064/Randomized-Placebo-Controlled-Trial-of-Green-Tea

Randomized, Placebo-Controlled Trial of Green Tea ... Preclinical, epidemiologic, and prior clinical trial data suggest that green tea catechins (GTC) may reduce prostate cancer risk.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2017/03310/green_tea_and_the_risk_of_prostate_cancer__a.17.aspx

Green tea and the risk of prostate cancer Our novel data demonstrated that higher green tea consumption was linearly reduced PCa risk with more than 7 cups/day and green tea catechins were effective ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622160943

Molecular Targets for Green Tea in Prostate Cancer ... At least two epidemiological studies (30, 31) show that people who regularly consume tea have a lower incidence of PCa. Because of these encouraging facts, we ...

7. mdpi.com mdpi.com/2072-6694/14/16/3988

Effects of Green Tea Catechins on Prostate Cancer ... In a meta-analysis of 9 case-control studies, there was a statistically significant 57% lower risk of PCa, comparing subjects with the highest relative to ...