Green Tea for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+329 other locations
Overseen byNagi B Kumar
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.
12345Is 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.
12678How 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.
12359Eligibility 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.
+13 more
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
+3 more
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (green tea catechins)Experimental Treatment3 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 Group3 Interventions
Patients receive placebo PO BID for up to 6 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mercy Cancer Center - CarmichaelCarmichael, CA
Rocky Mountain Regional VA Medical CenterAurora, CO
UCHealth University of Colorado HospitalAurora, CO
Fairbanks Memorial HospitalFairbanks, AK
More Trial Locations
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Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Modulation of signaling pathways in prostate cancer by green tea polyphenols. [2022]Prostate cancer (PCa) is the most common malignancy found in American men and the risk factors for PCa include age, family history, ethnicity, hormonal status, diet and lifestyle. For the successful development of cancer-preventive/therapeutic approaches, consumption of dietary agents capable of inhibiting or delaying the growth and proliferation of cancer cells without significantly affecting normal cells could be an effective strategy. Polyphenols derived from green tea, termed as green tea polyphenols (GTP) have received great attention in recent years for their beneficial effects, in particular, their significant involvement in cancer chemoprevention and chemotherapy. Several studies have reported beneficial effects of GTP using in vitro and in vivo approaches and in human clinical trials. Among green tea catechins, epigallocatechin-3-gallate (EGCG) is best studied for its cancer preventive properties. In this review article, we present available scientific literature about the effects of GTP and EGCG on signaling pathways in PCa.
Multitargeted therapy of cancer by green tea polyphenols. [2022]Tea ranks second only to water as a major component of fluid intake worldwide and has been considered a health-promoting beverage since ancient times. For the past two decades, we and others have been investigating the potential cancer preventive and therapeutic effects of green tea and its polyphenolic mixture termed GTP. It has become clear that much of these effects of GTP are mediated by its most abundant catechin, epigallocatechin gallate (EGCG). Large amount of encouraging data from in vitro and animal models has emerged making clear that green tea is a nature's gift molecule endowed with anticancer effects. Epidemiological and geographical observations suggest that these laboratory data may be applicable to human population. Clinical trials of GTP, especially in prostate cancer patients have yielded encouraging results. This article briefly reviews properties of GTP, especially EGCG with reference to multitargeted therapy of cancer.
Chemopreventive effects of tea in prostate cancer: green tea versus black tea. [2021]The polyphenol compositions of green tea (GT) and black tea (BT) are very different due to post-harvest processing. GT contains higher concentrations of monomeric polyphenols, which affect numerous intracellular signaling pathways involved in prostate cancer (CaP) development. BT polymers, on the other hand, are poorly absorbed and are converted to phenolic acids by the colonic microflora. Therefore, after consumption of GT, higher concentrations of polyphenols are found in the circulation, whereas after BT consumption the phenolic acid levels in the circulation are higher. The majority of in vitro cell culture, in vivo animal, and clinical intervention studies examine the effects of extracts of GT or purified (-)-epigallocatechin-3-gallate (EGCG) on prostate carcinogenesis. These studies provide strong evidence supporting a chemopreventive effect of GT, but results from epidemiological studies of GT consumption are mixed. While the evidence for a chemopreventive effect of BT is much weaker than the body of evidence with regard to GT, there are several animal BT intervention studies demonstrating inhibition of CaP growth. This article will review in detail the available epidemiological and human clinical studies, as well as animal and basic mechanistic studies on GT and BT supporting a chemopreventive role in CaP.
Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. [2022]Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.
Protective effects of green tea against prostate cancer. [2022]Prostate cancer has the third highest incidence of all cancers in men worldwide with incidence and mortality being particularly high in affluent, developed countries. Tea, especially green tea, has demonstrated promise in the prevention of several cancers. Green tea contains several components including catechins, a category of polyphenols that have chemopreventive properties. Although evidence from epidemiological studies is not comprehensive, it is strengthened by animal and in vitro evidence suggesting that consumption of tea is associated with decreased risk or progression of prostate cancer. Emerging evidence and potential biological mechanisms for the role of green tea in prostate cancer prevention are presented in this review.
Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention. [2022]Preclinical, epidemiologic, and prior clinical trial data suggest that green tea catechins (GTC) may reduce prostate cancer risk. We conducted a placebo-controlled, randomized clinical trial of Polyphenon E (PolyE), a proprietary mixture of GTCs, containing 400 mg (-)-epigallocatechin-3-gallate (EGCG) per day, in 97 men with high-grade prostatic intraepithelial neoplasia (HGPIN) and/or atypical small acinar proliferation (ASAP). The primary study endpoint was a comparison of the cumulative one-year prostate cancer rates on the two study arms. No differences in the number of prostate cancer cases were observed: 5 of 49 (PolyE) versus 9 of 48 (placebo), P = 0.25. A secondary endpoint comparing the cumulative rate of prostate cancer plus ASAP among men with HGPIN without ASAP at baseline, revealed a decrease in this composite endpoint: 3 of 26 (PolyE) versus 10 of 25 (placebo), P
Induction of apoptosis in prostate cancer cell lines by the green tea component, (-)-epigallocatechin-3-gallate. [2022]Green tea components exert many biological effects, including antitumor and cancer preventive activities. In the search for anticancer agents for prostate cancer the inhibitory effects of green tea components were tested on the prostate cancer cell lines LNCaP, PC-3 and DU145. (-)-Epigallocatechin-3-gallate (EGCG) proved to be the most potent catechin at inhibiting cell growth. The inhibition induced by EGCG was found to occur via apoptotic cell death as shown by changes in nuclear morphology and DNA fragmentation. Thus, we report the first evidence that EGCG is the active component in green tea and induces apoptosis in human prostate cancer cells.
Green tea polyphenols and cancer chemoprevention of genitourinary cancer. [2020]Green tea, which has higher concentrations of polyphenols than other teas, has been correlated with reduced risk of various malignancies with most data supporting a potential protective role in prostate neoplasia. Preclinical studies over the last 25 years implicate constituent green tea catechins, epigallocatechin-3-gallate (EGCG) being the predominant form, as the main mechanistic ingredient in the observed biologic effects, which vary from proapoptotic effects to inhibition of androgen receptor and signal transduction pathways. There have been few prospective clinical trials of green tea polyphenols (GTP), especially with well-characterized formulations and doses. Although there have been hints of beneficial clinical activity in prostate neoplasia, other studies have raised concerns about the limited bioavailability and very low target-tissue concentrations of GTPs. At present there is no proven role for GTP supplementation in the prevention of genitourinary (GU) malignancies, but novel GTP formulations and further clinical testing may still support a future for GTP supplementation in GU cancer prevention.
Growth inhibition and regression of human prostate and breast tumors in athymic mice by tea epigallocatechin gallate. [2022]The human prostate cancer cell lines, PC-3 (androgen-insensitive) and LNCaP 104-R (androgen-repressed) were inoculated subcutaneously into nude mice to produce prostate tumors. Intraperitoneal injection of green tea (-)epigallocatechin-3-gallate but not structurally related catechins, such as (-)epicatechin-3-gallate, inhibited the growth and rapidly reduced the size of human prostate tumors in nude mice. (-)Epigallocatechin-3-gallate also rapidly inhibited the growth of tumor growth formed by the human mammary cancer cell line MCF-7 in nude mice. It is possible that there is a relationship between the high consumption of green tea and the low incidence of prostate and breast cancers in some Asian countries.