Protocol: ECOG – EA8184
Please Note: Below is partial eligibility, for full eligibility requirements, please contact Genesys Hurley Cancer Institute Research Department at (810) 762-8181, (810) 762-8079, and/or (810) 762-8038. Thank you!
Eligibility:
(Step 0: Screening):
1. Patient must be ≥ 21 years of age.
2. Patient must speak English or Spanish.
3. 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 mpMRI-Prostate or TP Biopsy or TRUS Biopsy.
4. Patient must be on active surveillance.
5. Patient’s baseline biopsy must have occurred at least 6 months but not more than 18 months prior to preregistration to Step 0. NOTE: Patient is to be scheduled for a follow-up prostate biopsy 6
months after the initiation of treatment on this study.
6. Patient must have a serum PSA < 10 ng/mL or PSAD <0.15 ng/mL/ g obtained within 30 days of preregistration.
7. Patient must have an ECOG performance status 0−1.
8. Patient must be willing to abstain from consumption of any supplements containing green tea catechins.
9. 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).
10. Patient must be willing to discontinue current vitamin/mineral supplement use if it contains green tea products and use one provided by study.
11. Patient must be willing to take study agent or placebo at the dose specified with meals.
12. 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 androgendeprivation therapy.
13. Patient must not have prostate cancer with distant metastases.
14. 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.
(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 confirmed via central review.
- Patient must have % Ki-67 Expression of 3% or more in at least 1 core positive for tumor confirmed via central review.