RESUMEN
PURPOSE: The bicentric HypoFocal phase 2 trial investigates the implementation of molecular imaging with positron-emission tomography targeting prostate-specific membrane antigen (PSMA-PET) into modern focal dose-escalation radiation therapy (RT) concepts in 2 nonrandomized arms. We present the planned safety analysis after 6 months of follow-up. MATERIALS AND METHODS: Intermediate- and high-risk localized primary prostate cancer patients staged with multiparametric magnet resonance tomography and PSMA-PET were either treated with focal dose-escalated moderately hypofractionated RT (arm A) or single fraction high-dose-rate brachytherapy followed by external beam RT (arm B). PSMA-PET was used in addition to primary prostate cancer to define the intraprostatic gross tumor volume. Gastrointestinal and genitourinary toxicities were assessed according to Common Toxicity Criteria for Adverse Events (version 5.0) criteria. International Prostate Symptom Score was measured and quality of life assessed with European Organisation for Research and Treatment of Cancer questionnaires QLQ-PR25/-PR30. We enrolled 25 patients in each study arm. RESULTS: The implementation of PET-information led to large median volumes for dose escalation: 10.2 mL in arm A and 6.8 mL in Arm B. RT dose-escalation was feasible in all patients of arm A with up to 75 Gy (20 fractions) and in 23 patients with up to 19 Gy (1 fraction) in arm B. Toxicities, International Prostate Symptom Scores, and European Organisation for Research and Treatment of Cancer quality of life scores were not significantly different between baselines and 6 months follow-up in both arms. No grade 3 toxicities were observed at 6 months follow-up. CONCLUSIONS: This is the first prospective data supporting the feasibility of PSMA-PET-implementation into definitive focal dose-escalated RT. Patients maintained a good quality of life and a low toxicity profile after 6 months of follow-up.