About this trial
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
Qualifiers
Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
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)
WHO PS 0-1
Age ≥18 years
Disqualifiers
Patients with a pT4 tumor at prostatectomy
Patients with previously pathologically confirmed N1
Patients with macroscopically involved margin at surgery (R2)
Patients with a history of distant metastases
Trial design
Treatments tested in this trial
- Stereotactic body radiotherapy (SBRT)
- SOC RT