The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer.
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.
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.
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Newark Beth Israel Medical Center
- Rutgers University
Inclusion Criteria: - Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer - High-risk disease defined as having at least one or more of the following: - cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not allowed - The patient's prostate specific antigen (PSA) value > 20 ng/mL prior to starting androgen deprivation therapy (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 - Gleason Score of 8-10 - 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 prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute - Age >= 18 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 - 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 luteinizing hormone releasing hormone [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 - Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.