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Cancer Preventive Agent
Green Tea for Prostate Cancer
Phase 2
Recruiting
Led By Nagi B Kumar
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Summary
This trial looks at whether green tea catechins can prevent prostate cancer from progressing in men who are being closely monitored for the disease.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include digestive issues due to green tea extracts such as stomach upset or constipation, and possible allergic reactions for those sensitive to components of green tea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the highest percent Ki-67 expression
Secondary study objectives
Apoptosis
Apoptosis ratio
Change in geometric mean of percent Ki-67
+6 moreOther study objectives
Changes in lower urinary tract symptoms
Changes in lower urinary tract symptoms (LUTS)
Changes in quality of life (QOL)
+4 moreTrial Design
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 Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,640 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,449 Patients Enrolled for Prostate Cancer
ECOG-ACRIN Cancer Research GroupLead Sponsor
119 Previous Clinical Trials
178,687 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,562 Patients Enrolled for Prostate Cancer
Nagi B KumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to stop my current vitamins and use the study's supplements.I am scheduled for a prostate biopsy 6 months after starting treatment in this study.I am on a watchful waiting plan for my early-stage cancer.I have not received any treatment for prostate cancer before.I have no history of kidney or liver diseases, including hepatitis B or C.My prostate cancer has not spread to distant parts of my body.I am following a watchful waiting plan for my cancer, as recommended.My prostate cancer diagnosis was confirmed with a biopsy.I am scheduled for a prostate biopsy 6 months after starting treatment.I haven't had hormone, immunotherapy, chemotherapy, or radiation in the last 2 years.I am fully active or can carry out light work.I am willing to stop my current vitamins and use those provided by the study.I am HIV-positive, on treatment, and my viral load is undetectable.I am using contraception or abstaining from sex.I have a preserved tissue sample from my tumor for testing.My tumor sample is ready to be sent to H. Lee Moffitt Cancer Center.My Gleason score and Ki-67 levels will be confirmed by H. Lee Moffitt Cancer Center.My prostate cancer was confirmed with a biopsy showing cancer in at least one of the samples.You have a serum PSA < 10 ng/mL or a PSAD < 0.15 ng/mL/ g obtained within 30 days of registration.You need to limit your tea intake to less than three 8oz servings of hot or iced tea each week.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (green tea catechins)
- Group 2: Arm B (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Prostate Cancer Patient Testimony for trial: Trial Name: NCT04597359 — Phase 2
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