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)
Change in the highest percent Ki-67 expression — Baseline to 6 months Measured in a core positive for tumor from baseline to highest percent (%) Ki-67 expression measured in a core positive for tumor in the end of study (EOS) biopsy. This change will be compared between green tea catechins (GTC) and placebo arms. The highest % Ki-67 expressions from baseline and EOS biopsies will be used to estimate the change. If the change is not normally distributed, non-parametric test such as Wilcoxon-rank sum test or two-sample normal score test will be used to compare the changes in percent Ki-67 levels between the GTC and placebo arms.
Trial sites (353)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.