NCT06523634Recruiting
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 284 (estimated)
- First submitted
- 28 May 2024
- Start date
- 10 Dec 2024
- Primary completion date
- 1 Feb 2029
- Lead sponsor
- Jules Bordet Institute
- Diseases
- Prostate cancer
- NCT number
- NCT06523634
What you commit to
- Study type: Interventional
- Planned participants: 284
- From 10 Dec 2024 to the primary completion date, 1 Feb 2029
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZORG Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
| Ziekenhuis Aan de Stroom (ZAS) Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| Jules Bordet Institute, H.U.B Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Recruiting |
| CHU HELORA - Hôpital de La Louvière - site Jolimont Coordinator of this site? Confirm its status | La Louvière | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| AZ Sint Maarten Coordinator of this site? Confirm its status | Mechelen | Belgium | Recruiting |
| CHU UCL Namur - Site Elisabeth Coordinator of this site? Confirm its status | Namur | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc (UCLouvain) Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.