Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Recruiting · NCT06523634 · Interventional (participants receive a specific treatment) · Lead sponsor: Jules Bordet Institute
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
13 locations listed.
- AZorg - Aalst, Belgium
- Ziekenhuis Aan de Stroom (ZAS) - Antwerp, Belgium
- AZ Sint Jan - Bruges, Belgium
- Jules Bordet Institute, H.U.B - Brussels, Belgium
- Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan - Genk, Belgium
- UZ Gent - Ghent, Belgium
- Jessa Ziekenhuis - Hasselt, Belgium
- AZ Groeninge - Kortrijk, Belgium
- CHU HELORA - Hôpital de La Louvière - site Jolimont - La Louvière, Belgium
- UZ Leuven - Leuven, Belgium
- AZ Sint-Maarten - Mechelen, Belgium
- CHU UCL Namur - Site Elisabeth - Namur, Belgium
- Cliniques universitaires Saint-Luc (UCLouvain) - Woluwe-Saint-Lambert, Belgium