Protocol: ECOG – EA8184
Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact the GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
Pre-Registration – Step 0
- Must be at 21 years of age.
- 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 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 [local – Gleason 3+3 or Gleason 3+4) very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network (NCCN)].
- Patient’s baseline biopsy must have occurred at least 6 months but not more than 18 months prior to preregistration to Step 0.
- Patient must have a serum PSA < 10 ng/mL or PSAD <0.15 ng/mL/ g obtained within 30 days of registration.
- ECOG Performance Status 0-1.
- 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.
- 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. 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.