Study on Green Tea's Effectiveness in Slowing Prostate Cancer Progression in Men Under Close Monitoring

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04597359

Provider View

This clinical trial is exploring whether green tea catechins can help slow down the progression of prostate cancer in men who are being closely monitored. The study aims to see if green tea can stabilize the cancer and reduce the risk of it advancing to a more serious stage.

Patient Parameters

Program Overview

This phase II study is investigating how well green tea catechins work in preventing prostate cancer from progressing from a low-risk stage to higher-risk stages in men who are on active surveillance. The idea is that green tea catechins might help stabilize prostate cancer and lower the chance of it growing.

Description

The main goal of this study is to compare changes in a specific cancer marker, Ki-67, in prostate cancer tissue before and after treatment with green tea catechins or a placebo over six months. Researchers will also look at other factors, such as cancer cell death, the number of cancerous biopsy samples, and changes in prostate-specific antigen (PSA) levels. The safety of taking green tea catechins for six months will be evaluated through various health tests.

Participants will be randomly assigned to one of two groups. One group will take green tea catechins twice daily for up to six months, while the other group will take a placebo. After the study, participants will have follow-up visits at around 7 days, 6 months, and up to 12 months.

The study will also explore how well participants stick to the treatment, the bioavailability of green tea catechins, and any changes in urinary symptoms and quality of life. Participants will be asked to limit their intake of other green tea products and supplements during the study.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer with at least one positive biopsy core.
  • Must be on active surveillance for prostate cancer with low or favorable intermediate risk.
  • Must be scheduled for a follow-up prostate biopsy 6 months after starting the study.
  • Must have a PSA level below 10 ng/mL or a PSA density below 0.15 ng/mL/g.
  • Must have a good performance status (ECOG 0-1).
  • Must be willing to avoid green tea supplements and limit tea consumption.
  • Must be willing to use the vitamin/mineral supplement provided by the study.
  • Must be able to take the study treatment with meals.
  • Must understand and sign a written informed consent.
  • Must meet specific blood count and liver function criteria.
  • HIV-positive patients must have an undetectable viral load.
  • Sexually active males must use effective contraception or abstain from sex during the study.
  • Must have a tumor tissue sample available for analysis.

Exclusion Criteria

  • Must not have had prior treatment for prostate cancer, including surgery, radiation, or hormone therapy.
  • Must not have a history of kidney or liver disease, including hepatitis B or C.
  • Must not have prostate cancer that has spread to other parts of the body.
  • Must not have received treatment for any cancer within the past 2 years that could interfere with this study.
  • Must not be taking any other investigational drugs.
  • Must not have a history of allergic reactions to tea or similar compounds.

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