Actively Recruiting
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Led by Jules Bordet Institute · Updated on 2026-05-12
284
Participants Needed
13
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
INCLUSION CRITERIA
- 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 CRITERIA
- 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
- 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
- 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 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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
AZorg
Aalst, Belgium
Actively Recruiting
2
Ziekenhuis Aan de Stroom (ZAS)
Antwerp, Belgium
Actively Recruiting
3
AZ Sint Jan
Bruges, Belgium
Actively Recruiting
4
Jules Bordet Institute, H.U.B
Brussels, Belgium
Actively Recruiting
5
Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan
Genk, Belgium
Actively Recruiting
6
UZ Gent
Ghent, Belgium
Actively Recruiting
7
Jessa Ziekenhuis
Hasselt, Belgium
Actively Recruiting
8
AZ Groeninge
Kortrijk, Belgium
Actively Recruiting
9
CHU HELORA - Hôpital de La Louvière - site Jolimont
La Louvière, Belgium
Actively Recruiting
10
UZ Leuven
Leuven, Belgium
Actively Recruiting
11
AZ Sint-Maarten
Mechelen, Belgium
Actively Recruiting
12
CHU UCL Namur - Site Elisabeth
Namur, Belgium
Actively Recruiting
13
Cliniques universitaires Saint-Luc (UCLouvain)
Woluwe-Saint-Lambert, Belgium
Actively Recruiting
Research Team
R
Robbe Van den Begin, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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