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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the highest percent Ki-67 expression
Secondary outcome measures
Apoptosis
Apoptosis ratio
Change in geometric mean of percent Ki-67
+6 moreOther outcome measures
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
13,662 Previous Clinical Trials
40,925,713 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,735 Patients Enrolled for Prostate Cancer
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,562 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaging in this trial's protocol?
"The current study necessitates 360 patients that meet particular eligibility requirements to partake. Potential participants may join from The Carle Foundation Hospital in Urbana, Illinois and Lehigh Valley Hospital-Cedar Crest in Allentown, Pennsylvania."
Answered by AI
In which areas is this clinical investigation being conducted?
"At this time, the clinical trial is accepting enrollees in 100 cities. Among them are Urbana, Allentown and Stillwater as well as many others. To reduce travel requirements for participants, it's advised to pick a medical centre that lies close by."
Answered by AI
Are there still opportunities for participation in this research program?
"Yes, this trial is currently accepting participants. It was initially posted on May 20th 2021 and the most recent update occured on August 10th 2022 according to clinicaltrials.gov"
Answered by AI
Is Sinecatechins officially certified by the FDA?
"Although Phase 2 trials have demonstrated safety, the efficacy of Sinecatechins has yet to be backed up by clinical data. Therefore, our team at Power gave it a score of two on the risk scale."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Iowa
Other
Virginia
What site did they apply to?
Holy Cross Hospital
Trinity Regional Medical Center
Lehigh Valley Hospital-Hazleton
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
It seemed like a smart thing to do.
PatientReceived no prior treatments
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