Clinical trial · Interventional
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
NCT06508567CI-TRIAL-00112624SHAPE-PSMArecruitingN/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)
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.
Conditions
Conditions (2)
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Rate Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2xHDR Brachytherapy
- description
- Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy.
- interventionNames
- Radiation: High Dose Rate Brachytherapy
Primary outcomes (2)
- measure
- Dosimetry Parameters
- timeFrame
- 5 Years
- description
- As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
- measure
- Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
- timeFrame
- 5 Years
- description
- Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who received previous RT to the prostate bed +/- pelvic nodal regions 2. Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan 3. At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl 4. With or without ADT PSA doubling time from nadir greater than 6 months 5. ECOG 0-2 6. Age greater than 18 years Exclusion Criteria: 1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases 2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT 3. Any contraindications to MR and/or brachytherapy
References
Publications (0)
Data not yet available
No reference posted for this study.