StereoBed - salvage stereotactic body radiotherapy of the prostate bed for biochemical recurrence after radical prostatectomy: study protocol for a randomized phase II/III trial

Résumé fourni par la source

In cases of biochemical recurrence (BCR) after radical prostatectomy, salvage radiotherapy (RT) is a well-established standard-of-care treatment. Stereotactic body radiotherapy (SBRT) may offer a shorter treatment duration and favorable radiobiological characteristics, but evidence in the postoperative setting remains limited. This trial aims to compare genitourinary and gastrointestinal patient-reported outcomes after salvage SBRT with standard-of-care schedules. Two-hundred eighty-four patients with persistent or rising PSA levels after radical prostatectomy will be randomized in a 1:1 ratio to receive either a normofractionated or mildly hypofractionated RT schedule (64–70 Gy in 32–35 fractions or 52.5 Gy in 20 fractions, Arm A), or a SBRT schedule (32 Gy in 5 fractions, Arm B). Randomization will be stratified by study center and by the investigator’s treatment choices regarding standard-of-care androgen deprivation therapy (ADT; 6 months) and whole-pelvis radiotherapy (WPRT). The co-primary endpoints are the two-year change from baseline in the urinary and bowel domains of the EPIC-26 questionnaire. Secondary endpoints include patient-reported outcomes across all EPIC-26 domains, IPSS and EQ-5D-5 L scores up to 5 years, physician-reported toxicity according to CTCAE v5.0, biochemical progression-free survival (bPFS), distant metastasis-free survival (dmFS), local and regional control, overall survival (OS), cost-utility analysis based on EQ-5D-5 L compared with RT and transportation costs during treatment, and the lymphocyte nadir relative to baseline. This is one of the first multicenter randomized phase II/III trials designed to demonstrate that SBRT does not increase patient-reported gastrointestinal (GI) or genitourinary (GU) symptoms compared with standard-of-care (SOC) fractionations at the 2-year time point. ClinicalTrials.gov ID NCT06523634. Date of registration: May 28, 2024.

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