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Taking people in BelgiumNo phase

Tests focused radiation for prostate cancer returning after surgery

Tests focused radiation against standard radiotherapy in men with rising PSA after surgery.

Plain-language title generated from the registry record
Registry title: Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

Key facts

Where
Aalst, Antwerp, Bruges, Brussels, Genk, Ghent, Hasselt, Kortrijk, La Louvière, Leuven, Mechelen, Namur, and Woluwe-Saint-Lambert, BelgiumSee the 13 sites

Where in Belgium

  • AZORGAalst, BelgiumTaking people
  • Ziekenhuis Aan de Stroom (ZAS)Antwerp, BelgiumTaking people
  • AZ Sint JanBruges, BelgiumTaking people
  • Jules Bordet Institute, H.U.BBrussels, BelgiumTaking people
  • Ziekenhuis Oost-Limburg (ZOL) Campus Sint-JanGenk, BelgiumTaking people
  • UZ GentGhent, BelgiumTaking people
  • JESSA ZiekenhuisHasselt, BelgiumTaking people
  • AZ GroeningeKortrijk, BelgiumTaking people
  • CHU HELORA - Hôpital de La Louvière - site JolimontLa Louvière, BelgiumTaking people
  • UZ LeuvenLeuven, BelgiumTaking people
  • AZ Sint MaartenMechelen, BelgiumTaking people
  • CHU UCL Namur - Site ElisabethNamur, BelgiumTaking people
  • Cliniques Universitaires Saint-Luc (UCLouvain)Woluwe-Saint-Lambert, BelgiumTaking people

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Trial details

Who runs it
Jules Bordet Institute
Trial code
NCT06523634
Record updated
12 May 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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; Ability to understand and willingness to sign a study-specific informed consent prior to study entry; Ability to understand and answer the EPIC-26 form in one of the languages available.

Exclusion: Patients with previously pathologically confirmed N1; Patients with macroscopically involved margin at surgery (R2); Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate; Prior pelvic radiotherapy; Prior hormonal therapy started more than 6 weeks before randomization; History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery; Patients with a history of distant metastases; Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization; Patients with a pT4 tumor at prostatectomy; 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 considered as a pelvic recurrence; Latest PSA > 2ng/ml; Patients with a IPSS >20; Gleason 10 tumor.

ClinicalTrials.gov NCT06523634