January 24, 2022 Prostate

Protocol: ECOG – EA8184

Please Note:  Below is a partial list of eligibility, please contact the GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA EA8184

Pre-Registration – Step 0

  1. Must be at 21 years of age.
  2. 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.
  3. 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)].
  4. Patient’s baseline biopsy must have occurred at least 6 months but not more than 18 months prior to preregistration to Step 0.
  5. Patient must have a serum PSA < 10 ng/mL or PSAD <0.15 ng/mL/ g obtained within 30 days of registration.
  6. ECOG Performance Status 0-1.
  7. 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.
  8. Patient must not have prostate cancer with distant metastases.
  9. 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.
  10. 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.


October 12, 2020 Prostate

Protocol: NRG-GU005

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA NRG-GU005

  1. Previously untreated (no local therapy such as surgery, radiation cryotherapy, HIFU, etc.) localized adenocarcinoma of the prostate.
  2. Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland). (AJCC, version 7) or cT1a-c or 2a or 2b.
  3. Stages T1a-T1b are eligible if patient underwent TURP.
  4. The patient must meet one of the following 3 criteria: 1) Gleason score must be Gleason 7(3+4) with a PSA < 20 ng/mL, or 2) Gleason 6 (3+3) with a PSA > 10 ng/mL and < 20 ng/mL. (AJCC, version 7), or 3) Group Grade 1 or 2. If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment, the baseline PSA value may be double the initial value and the medication should be discontinued but a washout period is not required.
  5. At least 18 years of age.
  6. ECOG Performance Status 0-1

Ineligibility:

  1. Definitive clinical or radiologic evidence of metastatic disease. No nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis.
  2. Definitive T3 disease on MRI.
  3. Prior or current invasive malignancy with current evidence of active disease within the past 2 years.  Exceptions: Non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma.
  4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment for at least 3 years.
  5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  6. The use of hormonal therapy is not allowed. If the patient in on a 5-alpha reductase inhibitor, then they should be stopped prior to treatment once enrolled onto the study. No washout period is required for this study to participate.

 


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