Stereotactic Body Radiation Therapy for the Treatment of Patients with Advanced Prostate Cancer, PRORAD-5 Trial

Inclusion Criteria

• Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate within one year of study entry. Evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson. * cT1c-T3a by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th Edition [Ed.]). No cT3b-4 by digital exam or imaging (AJCC 8th Ed.) * Gleason grade group 2-5 (Gleason 7, 8, 9, 10). * If Gleason grade 2, must meet definition of unfavorable intermediate risk (at least one of the following: cT2b, prostate specific antigen [PSA] > 10 ng/mL prior to starting androgen deprivation therapy [ADT]. If a patient is taking 5-alpha reductase inhibitors the measured PSA may be doubled)
• Node negative by conventional imaging
• Be ≥ 18 years of age on the day of signing informed consent
• 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: baseline PSA must be obtained prior to the start of any androgen deprivation therapy (ADT)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria

• Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe RT
• Prior prostatectomy, cryosurgery, or high-intensity focused ultrasound ablation (HIFU) for adenocarcinoma of the prostate
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
• Distant metastatic disease on conventional imaging, which by the discretion of the treating physician cannot be treated definitively