Clinical trial · Interventional
MRI-guided Brachytherapy and Salvage SBRT Program
MRI-guided Brachytherapy + Salvage SBRT Program for Patients With Prostate Bed Relapses After Radical Prostatectomy
NCT07132671CI-TRIAL-00093901not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Post Prostatectomy) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy and MR-Guided SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-guided Brachytherapy and Salvage SBRT Program
- description
- Brachytherapy and MR-guided SBRT
- interventionNames
- Radiation: Brachytherapy and MR-Guided SBRT
Primary outcomes (2)
- measure
- Biochemical control
- timeFrame
- 5-year
- description
- To achieve 5-year biochemical control rate in 85% of the patients.
- measure
- Adverse Events
- timeFrame
- 5-year
- description
- To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and RMN+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement. 1. Pathological confirmation is advised in all cases but it is not mandatory . 2. Patients with any of the following were not considered eligible: 1. Distance \< 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter) 2. Distant Metastases 3. Isolated nodal relapses 4. Prior Irradiation to the IPBR area 5. Multicentric IPBRs 6. Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure 3. No prior radiation therapy to the target areas; 4. Karnofsky performance status \> 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy; 5. WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0. 6. Ability to undergo MRI scanning.
References
Publications (0)
Data not yet available
No reference posted for this study.