Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

October 12, 2020

Clinical Trial Information

Schema NRG GU005

Protocol: NRG-GU005

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

  1. Previously untreated (no local therapy such as surgery, radiation cryotherapy, HIFU, etc.) localized adenocarcinoma of the prostate with the following clinical findings:
    • 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.
    • Stages T1a-T1b are eligible if patient underwent TURP;
    • 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.
    o 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. To be eligible, a PSA drawn while still on the medicine must be:                                                                                                                                                                                                                         <10ng/mL if Gleason 7(3+4) (note this patient would be on stratification level 1 if PSA < 5ng/mL and stratification level 2 if less than 10 ng/mL).
    >5ng/mL and less than 10 ng/mL for Gleason 6(3+3) (note this patient would be on stratification level 3.)                                               The prostate volume must be < 70 cc as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan.
    Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements.
  2. Age ≥ 18.
  3. ECOG Performance Status 0-1 60 days prior to registration.
  4. MRI of the prostate and pelvis (compliant with PIRADSv2.1 guidelines) within 1 year prior to registration.
  5. Bone scan as clinically indicated within 120 days prior to registration.
  6. Charlson modified co-morbidity score ≤4 for patients under 60 and ≤5 for patients 60.
  7. International Prostate Symptom Score (IPSS) of <15 21 days prior to registration.

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.
  7. Severe, active co-morbidity.

 

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