Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
NCT06523634 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284
Last updated 2026-05-12
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.
Conditions
Interventions
- 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))
Sponsors & Collaborators
-
Jules Bordet Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-10
- Primary Completion
- 2029-02-01
- Completion
- 2032-02-01
Countries
- Belgium
Study Locations
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