Elective Nodal Ultra Hypofractionated Radiation for Prostate Cancer: Safety and Efficacy From Four Prospective Clinical Trials

Abstract

The role of elective nodal irradiation (ENI) in localized prostate cancer (PCa) is controversial. With the increasing use of SBRT to the prostate, data is needed regarding the safety and efficacy of ENI using ultra-hypofractionated radiation (UHRT).Between 2013 and 2020, 4 prospective clinical trials of intermediate or high-risk PCa receiving dose-escalated RT to the prostate (via either HDR brachytherapy or SBRT boost) and ENI using UHRT (25Gy in 5 weekly fractions) were conducted. Primary endpoints included acute genitourinary and gastrointestinal toxicities (CTCAE v3.0/4.0), and secondary endpoints included late genitourinary and gastrointestinal toxicities and biochemical failure (Phoenix definition).One hundred sixty-five patients were enrolled, of whom 98 (59%) had high risk disease. ADT was used in 141 (85%). Median follow-up was 38 months (IQR 10-63). The worst acute genitourinary and gastrointestinal toxicities respectively were 48% and 7.5% for grade 2, and 2.7% and 0% for grade 3. Cumulative incidence of late grade 2+ genitourinary and gastrointestinal toxicities at 36 months were 58% and 11.3% and for late grade 3+ toxicities were 1% and 0%, respectively. No grade 4+ acute or late toxicities were observed. The 3-year biochemical recurrence-free survival was 98%.ENI using UHRT is associated with low incidence of grade 3+ toxicity, while grade 1-2 acute genitourinary and gastrointestinal toxicity is common. Randomized phase 3 trials are needed.