Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Trial Parameters
Brief 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.
Eligibility Criteria
INCLUSION CRITERIA 1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent. 2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \>0.1 ng/mL , or three consecutive PSA rises) 3. WHO PS 0-1 4. Age ≥18 years 5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry 6. Ability to understand and answer the EPIC-26 form in one of the languages available EXCLUSION CRITERIA 1. Patients with a pT4 tumor at prostatectomy 2. Patients with previously pathologically confirmed N1 3. Patients with macroscopically involved margin at surgery (R2) 4. Patients with a history of distant metastases 5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \>1cm and/or positive on PSMA without other explanation, are consider