Clinical trial · Interventional
MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)
Improved MR-Guided Single-fraction Stereotactic Sblative Radiotherapy in Pelvic and Abdominal Nodal Oliorecurrent Prostate Cancer
- 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 single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative treatment. Participants receive one fraction of 24 Gy delivered with MR-guided stereotactic body radiotherapy (SBRT), which uses MRI to visualise the tumour and surrounding organs during treatment. The main goal is to assess safety (severe side effects). The trial also evaluates local tumour control, longer-term side effects, time until hormone (androgen deprivation) therapy is needed, survival, and quality of life. The trial aims to enrol 48 patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nodal Oligorecurrent Prostate Cancer | — | UNRESOLVED | — |
| Oligometastatic Cancer | — | UNRESOLVED | — |
| Oligo-metastatic Prostate Carcinoma | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single-fraction SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-fraction MR-guided SBRT
- description
- All participants receive 24 Gy in a single fraction to the GTV, delivered with MR-guided SBRT.
- interventionNames
- Radiation: Single-fraction SBRT
Primary outcomes (1)
- measure
- Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events
- timeFrame
- Within 6 months after completion of radiotherapy
- description
- The NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measures side-effects. Possible scores range from 0-5, with higher scores indicating a worse outcome.
Secondary outcomes (9)
- measure
- Number of participants with late adverse events (CTCAE v5.0)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Signed informed consent * Histologically proven initial diagnosis of adenocarcinoma of the prostate * ECOG performance status 0-2 * Biochemical recurrence after curatively intended local treatment (radical prostatectomy and/or radiotherapy), with PSMA-PET/CT-verified nodal relapse in the pelvis or abdomen * Any additional sites of disease beyond the protocol-specified target lymph nodes must be considered suitable for ablative treatment * Life expectancy \> 6 months * Lymph node size ≤ 2 cm Exclusion Criteria: * Medical contraindications to MRI * Inability to tolerate the physical set-up required for SABR * Overlap between prior radiation fields and the current target area leading to high risk of clinically significant normal-tissue injury * Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease) * Uncontrolled intercurrent illness
References
Publications (0)
Data not yet available