Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Stereotactic Body Radiation Therapy (SBRT): Patients undergo Stereotactic Body Radiation Therapy (SBRT) at least every other day for 2-3 fractions per week for 5 fractions over less tha
Sponsors
NRG Oncology
Eligibility
Inclusion criteria
Inclusion criteria: Patient Selection, Eligibility, and Ineligibility Criteria 1 Patient Selection Guidelines Although the guidelines provided below are not inclusion/exclusion criteria, investigators should consider these factors when selecting patients for this trial. Investigators also should consider all other relevant factors (medical and non-medical), as well as the risks and benefits of the study therapy, when deciding if a patient is an appropriate candidate for this trial. 1.1 Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up. 1.2 Men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment and for 6 months afterward. 1.3 Submission of original biopsy material for testing is optional for all patients. Investigators should check with their site Pathology department regarding release of biospecimens before approaching patients about participation in the trial. 2 Eligibility Criteria A patient cannot be considered eligible for this study unless ALL of the following conditions are met. 2.1 Previously untreated (no local therapy such as surgery, radiation cryotherapy, HIFU, etc.) localized adenocarcinoma of the prostate with the following clinical findings: i. 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. ii. 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 10 ng/mL and 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: >5ng/mL and less than 10 ng/mL for Gleason 6(3+3) (note this patient would be on stratification level 3.) iii. Percent of submitted positive core biopsies must be NOTE: all cores from a targeted lesion will be counted as an N of 1 core for calculating percent positive cores in total. iv. The prostate volume must be v. Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements 2.2 Age >= 18 2.3 History and physical including a digital rectal exam 60 days prior to registration. 2.4 ECOG Performance Status 0-1 60 days prior to registration. 2.5 MRI of pelvis (compliant with PIRADSv2 guidelines) within 90 days prior to registration. 2.6 Bone scan as clinic
Exclusion criteria
Exclusion criteria: 3 Ineligibility Criteria Patients with any of the following conditions are NOT eligible for this study. 3.1 Definitive clinical or radiologic evidence of metastatic disease. No nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis. 3.2 Definitive T3 disease on MRI 3.3 Prior or current invasive malignancy with current evidence of active disease within the past 3 years. 3.4 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. [Applicable only to studies that incorporate systemic therapy]; 3.5 Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 3.6 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. 3.7 Severe, active co-morbidity defined as follows: • HIV positive with CD4 count = 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive. • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.) 3.8 Contraindication to MRI • Cardiac pacemaker or defibrillator • Surgically implanted electrical devices such as spinal stimulation devices or intracranial stimulation devices, cochlear implants, the presence of metallic foreign bodies in the orbits, and incompatible old mechanical heart valves and aneurysm clips
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome 1: Patient-reported GI and GU toxicity, as measured by EPIC-26 bowel and urinary irritation domains Outcome 2: DFSTimepoint: Outcome 1: Two years Outcome 2: Two years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Secondary HRQOL endpoints (distinct from primary), as measured by EPIC-26 2. Local and regional failure 3. Distant metastasis 4. Prostate cancer specific survival 5. Local failure 6. Regional failure 7. Overall Survival 8. Biochemical failure Timepoint: Two years to five years | — |
Countries
Canada, India, Ireland, United States of America
Contacts
Public ContactRahul Krishnatry
Tata Memorial Hospital
Outcome results
None listed