Status:
RECRUITING
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Lead Sponsor:
Jules Bordet Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 ra...
Detailed Description
This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed. All subjects will be randomly assigned in a 1:1 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2032
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT06523634
Start Date
December 10 2024
End Date
February 1 2032
Last Update
January 6 2026
Active Locations (12)
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1
AZorg
Aalst, Belgium
2
GZA Ziekenhuis ZAS Kempenstraat
Antwerp, Belgium
3
Ziekenhuis Aan de Stroom (ZAS)
Antwerp, Belgium
4
AZ Sint Jan
Bruges, Belgium