NCT06523634 Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
| NCT ID | NCT06523634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jules Bordet Institute |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 284 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 284 participants in total. It began in 2024-12-10 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 radical prostatectomy.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06523634 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06523634 currently recruiting?
Yes, NCT06523634 is actively recruiting participants. Contact the research team at robbe.vandenbegin@hubruxelles.be for enrollment information.
Where is the NCT06523634 trial being conducted?
This trial is being conducted at Aalst, Belgium, Antwerp, Belgium, Bruges, Belgium, Brussels, Belgium and 9 additional locations.
Who is sponsoring the NCT06523634 clinical trial?
NCT06523634 is sponsored by Jules Bordet Institute. The trial plans to enroll 284 participants.
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