NCT06523634

Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.

Detailed description

This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed. All subjects will be randomly assigned in a 1:1 ratio: 1. Experimental arm: Radiotherapy treatment in 5 fractions. 2. Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiotherapy (SBRT)	5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.
RADIATION	SOC RT	Standard salvage radiotherapy to the prostate bed with or without whole pelvic radiotherapy. Each participating centre can specify upfront which RT schedule will be used in the control arm, with the choice between the following schedules: * Hypofractionated: 20 fractions (Daily treatment (OTT 4-5 weeks)) * Normofractionated: 32-35 fractions (Daily treatment (OTT 7-8 weeks))

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-02-01
• Completion: 2032-02-01
• First posted: 2024-07-26
• Last updated: 2026-03-12

Locations

12 sites across 1 country: Belgium