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Clinical Trials in Mexico / NCT04597359
Active, not recruiting Phase 2

To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring

NCT04597359 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 2
Started
2021-10-05
Last updated
2026-09-04

Condition(s) studied

Prostate Carcinoma

Investigational drug(s) / intervention(s)

Placebo AdministrationQuality-of-Life AssessmentQuestionnaire AdministrationSinecatechins

Placebo Administration: Given PO

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Sinecatechins: Given PO

Study summary

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * INCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING) * Patient must have biopsy-proven (consisting of \>= 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using initial transrectal ultrasound (TRUS) biopsy or TRUS biopsy followed by multiparametric magnetic resonance imaging (mpMRI) of the prostate and a confirmatory targeted biopsy * Patient must be on active surveillance (very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network \[NCCN\]) * Patient must be scheduled for a follow up prostate biopsy 6 months after the initiation of treatment on this study * Patient must have a serum PSA \< 10 ng/mL or prostate specific antigen density (PSAD) \< 0.15 ng/mL/ g obtained within 30 days of registration * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patient must be willing to abstain from consumption of any supplements containing green tea catechins * Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz) * Patient must be willing to discontinue current vitamin/mineral supplement use and use one provided by study * Patient must be willing to take study agent or placebo at the dose specified with meals * Patient must have the ability to understand and the willingness to sign a written informed consent document * Absolute neutrophil count \>= 1,200/mm\^3 (\>= 1.2 k/uL) (obtained within 30 days prior to registration) * Platelets \>= 75,000/mm\^3 (\>= 75 k/uL) (obtained within 30 days prior to registration) * Total bilirubin =\< 1.2 mg/dL (or =\< 3.0 mg/dL for patients with Gilbert's syndrome) (obtained within 30 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x upper limit of normal (ULN) (obtained within 30 days prior to registration) * Serum creatinine =\< 1.5 x ULN (obtained within 30 days prior to registration) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Sexually active males must use an accepted and effective method of double barrier contraception (vasectomy must be combined with a physical barrier method) or abstain from sexual intercourse for the duration of their participation in the study * Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening * Tumor tissue specimen has been collected and is ready to ship to H. Lee Moffitt Cancer Center \& Research Institute * H. Lee Moffitt Cancer Center \& Research Institute will perform Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue and notify the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Operations Office and submitting institution within 3-4 business days of receipt of the tumor tissue specimen * INCLUSION CRITERIA FOR RANDOMIZATION (STEP 1) * Patient must meet all Step 0 eligibility criteria at the time of their registration to Step 1 * Patient must have Gleason score (3+3) or predominant Gleason pattern 3 (3+4), =\< 33% of biopsy cores, and =\< 50% involvement of any biopsy core * Patient must have % Ki-67 expression of 5% or more in tumor tissue Exclusion Criteria: * EXCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING) * Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen deprivation therapy * Patient must not have a history of renal or hepatic disease, including history of hepatitis B and C * Patient must not have prostate cancer with distant metastases * Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must not receive any other investigational agents while on this study * Patient must not have a history of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to green tea extracts

Primary outcome measure(s)

Trial sites (353)

FacilityCityRegionStatus
Fairbanks Memorial Hospital Fairbanks Alaska
Cancer Center at Saint Joseph's Phoenix Arizona
Highlands Oncology Group - Fayetteville Fayetteville Arkansas
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
CARTI Cancer Center Little Rock Arkansas
Highlands Oncology Group - Rogers Rogers Arkansas
Highlands Oncology Group Springdale Arkansas
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
Marshall Cancer Center Cameron Park California
Mercy Cancer Center - Carmichael Carmichael California
Mercy San Juan Medical Center Carmichael California
Epic Care-Dublin Dublin California
Mercy Cancer Center - Elk Grove Elk Grove California
Bay Area Breast Surgeons Inc Emeryville California
Epic Care Partners in Cancer Care Emeryville California
UC San Diego Health System - Encinitas Encinitas California
UC San Diego Moores Cancer Center La Jolla California
Contra Costa Regional Medical Center Martinez California
Mercy Cancer Center Merced California
Alta Bates Summit Medical Center - Summit Campus Oakland California
Bay Area Tumor Institute Oakland California
Marshall Hospital Placerville California
Mercy Cancer Center - Rocklin Rocklin California
Mercy Cancer Center - Sacramento Sacramento California
UC San Diego Medical Center - Hillcrest San Diego California
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
UCSF Cancer Center - San Mateo San Mateo California
Mission Hope Medical Oncology - Santa Maria Santa Maria California
Epic Care Cyberknife Center Walnut Creek California
BASS Medical Group - Lennon Walnut Creek California
Woodland Memorial Hospital Woodland California
Rocky Mountain Cancer Centers-Aurora Aurora Colorado
Rocky Mountain Regional VA Medical Center Aurora Colorado
UCHealth University of Colorado Hospital Aurora Colorado
Boulder Community Foothills Hospital Boulder Colorado
Rocky Mountain Cancer Centers-Boulder Boulder Colorado
Rocky Mountain Cancer Centers - Centennial Centennial Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado
Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado

+ 313 more sites — see the full list on the official registry below.

More ECOG-ACRIN Cancer Research Group trials in Mexico

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04597359 on ClinicalTrials.gov ↗ ← All trials in Mexico