Green Tea Extract for Prostate Cancer

Not currently recruiting at 1 trial location

Overseen By Nagi Kumar, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: 5-alpha-reductase inhibitors

Disqualifiers: Metastatic disease, Prior PCa treatment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether green tea extract (Sunphenon) can help manage prostate cancer in men under active surveillance. It compares the effects of the green tea extract to a placebo over two years to assess safety and effectiveness. Men with low to intermediate-grade prostate cancer, who haven't received other treatments and are willing to adjust their tea and supplement intake, might be suitable for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in prostate cancer management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must stop using any supplements containing green tea catechins and discontinue your current vitamin/mineral supplements to use the ones provided by the study.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must stop using any supplements containing green tea catechins and discontinue your current vitamin/mineral supplements to use the ones provided by the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that green tea extract, such as Sunphenon, is usually safe for use. One study found that about 338 mg per day of a compound in green tea, called EGCG, is safe. This conclusion comes from both animal and human safety studies.

Another study examined natural compounds in green tea, known as catechins, and found they offer health benefits without major side effects. In the past, users of green tea extracts reported few problems. Some minor issues like stomach upset or headaches were noted, but these were uncommon.

As Sunphenon undergoes this trial, it remains in an early stage. This phase helps researchers learn more about the treatment's safety for people. While the safety data appears promising, studies like this one are essential to confirm it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Green tea extract, specifically Sunphenon, is unique because it uses a natural compound rich in catechins, which are believed to have anti-cancer properties. Unlike the standard treatments for prostate cancer that often involve hormone therapy, surgery, or radiation, this approach targets the cancer cells differently, potentially reducing side effects associated with traditional methods. Researchers are excited about Sunphenon because it represents a gentler, plant-based intervention that could complement existing therapies or offer an alternative for those looking for less invasive options.

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

Research has shown that green tea catechins, such as those in Sunphenon, might help lower the risk of prostate cancer. A review of studies found that people who drink a lot of green tea have a 57% lower risk of prostate cancer compared to those who drink little. Some studies also suggest that green tea might reduce the risk of other cancers, like stomach and esophagus cancer. However, not all studies found a strong connection between green tea and a lower risk of prostate cancer. Overall, the evidence is promising, but results are mixed, and more research is needed. Participants in this trial will receive either Sunphenon, a standardized formulation of green tea catechins, or a placebo to further investigate these potential benefits. ^{3 4 5 6 7}

Who Is on the Research Team?

Nagi Kumar, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

Men 18 or older with low to intermediate grade prostate cancer managed on active surveillance can join. They must have a PSA <10 ng/mL, no history of serious kidney or liver disease, and agree to limit tea intake and not use other vitamin/mineral supplements during the trial. Prior treatments for prostate cancer or recent use of certain medications disqualify participation.

Inclusion Criteria

Willing to restrict tea consumption

My prostate cancer has a Gleason score of 3+3 or 3+4.

Meet hematological eligibility parameters

Exclusion Criteria

I have had treatment for prostate cancer, including surgery or hormone therapy.

I have taken medication for prostate enlargement in the last 3 months.

History of allergic reactions attributed to tea or compounds of similar composition to green tea extracts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Green Tea Catechins or placebo for 24 months, with monthly follow-up visits for monitoring and lab work

24 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Sunphenon

Trial Overview The study is testing Sunphenon (a green tea extract) against a placebo over two years to see if it's safe and effective in men with prostate cancer who are being closely monitored but not actively treated. The trial randomly assigns participants to either the supplement or placebo group without them knowing which one they're getting.

How Is the Trial Designed?

Group I: Sunphenon® 90D Experimental Treatment 1 Intervention

Participants will be administered a standardized formulation of whole Green Tea Catechin for 24 months. The daily dose of Green Tea Catechin will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

Group II: Placebo Placebo Group 1 Intervention

Participants will be administered a placebo for 24 months. The daily dose of placebo will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 113 men with prostate cancer, green tea (GT) consumption led to a significant reduction in nuclear NFκB levels and a decrease in serum prostate-specific antigen (PSA) levels, suggesting potential benefits for prostate cancer management.

While both green tea and black tea were tested, only green tea showed a systemic antioxidant effect and uptake of tea polyphenols in prostate tissue, indicating its unique role in influencing biomarkers related to prostate cancer development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of brewed green and black tea in men with prostate cancer prior to prostatectomy. Henning, SM., Wang, P., Said, JW., et al.[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]

In a study using TRAMP mice, the green tea polyphenol EGCG was found to significantly inhibit early-stage prostate cancer by reducing cell proliferation and inducing apoptosis, suggesting its potential as a chemopreventive agent.

EGCG's mechanism of action includes down-regulating key factors like the androgen receptor and IGF-1, as well as modulating inflammatory pathways, which may contribute to its effectiveness in suppressing prostate cancer without causing toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epigallocatechin-3-Gallate suppresses early stage, but not late stage prostate cancer in TRAMP mice: mechanisms of action. Harper, CE., Patel, BB., Wang, J., et al.[2022]

In a study using the TRAMP mouse model, oral infusion of a green tea polyphenolic fraction significantly inhibited prostate cancer development and metastasis, with a human-equivalent dose showing promising results.

The treatment led to a substantial reduction in tumor incidence, weight, and cancer cell proliferation, while also promoting apoptosis in cancer cells, suggesting a strong potential for green tea compounds in prostate cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of prostate carcinogenesis in TRAMP mice by oral infusion of green tea polyphenols. Gupta, S., Hastak, K., Ahmad, N., et al.[2022]

In a study involving 19 patients with hormone refractory prostate cancer, green tea extract capsules (250 mg twice daily) were generally well tolerated, with only two patients experiencing moderate to severe side effects, primarily gastrointestinal irritation.

Despite being well tolerated, green tea showed minimal clinical activity, as 9 out of 15 patients who completed at least 2 months of therapy experienced disease progression within that time frame.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective clinical trial of green tea for hormone refractory prostate cancer: an evaluation of the complementary/alternative therapy approach. Choan, E., Segal, R., Jonker, D., et al.[2022]

Green tea extract (GTE) has shown anticancer efficacy against PC3 prostate cancer cells by inhibiting the epithelial to mesenchymal transition (EMT) and increasing the expression of miR-195, which is associated with tumor suppression.

The study utilized both 2D and 3D cell culture models to analyze these effects, suggesting that GTE could be a valuable natural product in developing anti-tumor therapies, although further research is needed to fully understand the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of green tea extract on PC3 prostate cancer cells through upregulation of miR-195 expression and suppression of epithelial to mesenchymal transition. Safari, F., Dadeh Amirfard, K.[2023]

In a study involving 119 TRAMP mice, treatment with Polyphenon E, a green tea extract, significantly reduced the number and size of prostate tumors and decreased metastasis to distant sites, demonstrating its efficacy as a chemopreventive agent.

Long-term treatment (32 weeks) with Polyphenon E was found to be safe and well tolerated, with no signs of toxicity in the mice, indicating its potential for use in preventing prostate cancer progression without harmful side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and chemopreventive effect of Polyphenon E in preventing early and metastatic progression of prostate cancer in TRAMP mice. Kim, SJ., Amankwah, E., Connors, S., et al.[2022]

Green tea consumption may serve as an effective chemopreventive agent against prostate cancer, especially in individuals with high-grade prostate intraepithelial neoplasia, based on a systematic review of 15 studies.

While green tea shows promise in preventing prostate cancer, there is currently insufficient evidence to support its efficacy in treating the disease, highlighting the need for more rigorous randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Green Tea Consumption on Prostate Cancer Risk and Progression: A Systematic Review. Jacob, SA., Khan, TM., Lee, LH.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04300855

Clinical Trial of Green Tea Catechins in Men on Active ... This randomized double-blinded Phase II clinical trial will evaluate the bioavailability, safety, effectiveness and validate the mechanism by which a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5488006/

Green Tea Catechins for Prostate Cancer Prevention The authors did not find a significant association between green tea consumption and the global risk of being diagnosed with PCa. Nonetheless, a dose-dependent ...

3. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct04300855

Clinical Trial of Green Tea Catechins in Men on Active ... This randomized double-blinded Phase II clinical trial will evaluate the bioavailability, safety, effectiveness and validate the mechanism

4. 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 ...

5. 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 ...

6. blog-ecog-acrin.org blog-ecog-acrin.org/trial-spotlight-nagi-kumar-on-the-ea8184-study-for-men-with-low-grade-prostate-cancer-on-active-surveillance/

Trial Spotlight: Nagi Kumar on the EA8184 Study for Men with ... Overtreating low-grade prostate cancer increases the risk of treatment-related side effects while offering little to no cancer survival benefit.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0273230018300928

The safety of green tea and green tea extract consumption ... A safe intake level of 338 mg EGCG/day for adults was derived from toxicological and human safety data for tea preparations ingested as a solid bolus dose.