Ireland
--:--IST
Recruiting Not applicable

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

NCT06523634 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2024-12-10
Last updated
2026-05-12

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Stereotactic body radiotherapy (SBRT)SOC RT

Stereotactic body radiotherapy (SBRT): 5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.

SOC RT: Standard salvage radiotherapy to the prostate bed with or without whole pelvic radiotherapy. Each participating centre can specify upfront which RT schedule will be used in the control arm, with the choice between the following schedules: * Hypofractionated: 20 fractions (Daily treatment (OTT 4-5 weeks)) * Normofractionated: 32-35 fractions (Daily treatment (OTT 7-8 weeks))

Study 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 radical prostatectomy.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
INCLUSION CRITERIA 1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent. 2. 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) 3. WHO PS 0-1 4. Age ≥18 years 5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry 6. Ability to understand and answer the EPIC-26 form in one of the languages available EXCLUSION CRITERIA 1. Patients with a pT4 tumor at prostatectomy 2. Patients with previously pathologically confirmed N1 3. Patients with macroscopically involved margin at surgery (R2) 4. Patients with a history of distant metastases 5. 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. 6. Latest PSA \> 2ng/ml 7. Patients with a IPSS \>20 8. Gleason 10 tumor 9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate 10. Prior pelvic radiotherapy 11. Prior hormonal therapy started more than 6 weeks before randomization 12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery. 13. 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.

Primary outcome measure(s)

  • SBRT impact on patient-reported GI and GU symptoms — 2 years post treatment
    Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).

Trial sites (13)

FacilityCityRegionStatus
AZorg Aalst Belgium Recruiting
Ziekenhuis Aan de Stroom (ZAS) Antwerp Belgium Recruiting
AZ Sint Jan Bruges Belgium Recruiting
Jules Bordet Institute, H.U.B Brussels Belgium Recruiting
Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan Genk Belgium Recruiting
UZ Gent Ghent Belgium Recruiting
Jessa Ziekenhuis Hasselt Belgium Recruiting
AZ Groeninge Kortrijk Belgium Recruiting
CHU HELORA - Hôpital de La Louvière - site Jolimont La Louvière Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
AZ Sint-Maarten Mechelen Belgium Recruiting
CHU UCL Namur - Site Elisabeth Namur Belgium Recruiting
Cliniques universitaires Saint-Luc (UCLouvain) Woluwe-Saint-Lambert Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06523634 on ClinicalTrials.gov ↗ ← All trials in Belgium