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The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
Eligibility Criteria
Inclusion Criteria
- 1Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
- 2High-risk disease defined as having at least one or more of the following:
- 3cT3a-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
- 4The 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
- 5Gleason Score of 8-10
- 6Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
- 7Prostate 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
- 8No 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
- 9Age \>= 18
- 10Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- 11No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- 12No prior radical prostatectomy
- 13No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \[HIFU\], laser ablation, cryotherapy, irreversible electroporation \[IRE\], and vascular-targeted photodynamic therapy)
- 14Prior 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
- 15No contraindication to prostate MRI (required for planning of radiotherapy in both arms)
- 16Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
Locations
355 sites participating in this study
Emory Proton Therapy Center
Atlanta, Georgia 30308
Nikhil Sebastian
Emory University Hospital Midtown
Atlanta, Georgia 30308
Nikhil Sebastian
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Nikhil Sebastian