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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorJules Bordet Institute

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

Treatment groups

284 Participants
are divided into 2 treatment groups

Sponsors and collaborators