IRB Study Number NRG-GU013_Akron
Status Recruiting
Location Akron General
Institute Taussig Cancer Institute
Description
1.1 Primary Objective
To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (SBRT) to those randomized to moderate hypofractionation and conventional fractionation.
1.2 Secondary Objectives
• To compare physician-reported toxicity as measured by CTCAE v5 between treatment arms.
• To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by EPIC-26 urinary domains).
• To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain).
• To compare patient-reported fatigue (assessed by PROMIS-Fatigue) between treatment arms.
• To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity (COST)) between treatment arms.
• To compare failure-free survival between treatment arms.
• To compare metastasis-free survival based on molecular imaging between treatment arms.
• To compare overall survival between treatment arms.
Inclusion Criteria
3.2.1 Documentation of Disease
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer.
3.2.2 Definition of Disease
- High-risk disease defined as having at least one or more of the following:
o cT3a-T3b by digital exam or imaging (AJCC 8th Ed.) Note: cT4 by imaging or on digital rectal exam is not allowed.
o The patient’s PSA value >20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors.
o Gleason Score of 8-10
o Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan.
No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI);
Negative PSMA PET is an acceptable substitute.
3.2.3 Age ≥ 18
3.2.4 ECOG Performance Status of 0-2
3.2.5 Prior Treatment
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
• No prior radical prostatectomy;
• Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease in 3.2.2.
3.2.6 Co-Enrollment with NRG-GU009 (ONLY Applies to Patients enrolled in NRGGU009) Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy. For details, see Section 5.4.
Exclusion Criteria
Exclusion not available.
