PhD-student
Kristine Skovly Nielsen
Department of oncology, Odense University Hospital
| Project management | ||
| Project status | Open | |
| Data collection dates | ||
| Start | 01.10.2025 | |
| End | 01.10.2035 | |
Improved MR-guided single-fraction stereotactic ablative radiotherapy in pelvic and abdominal nodal oligorecurrent prostate cancer
Short summary
This prospective single-arm phase 2 study investigates the safety of single-fraction 24 Gy MR-guided stereotactic radiotherapy for pelvic and abdominal nodal oligorecurrent prostate cancer. The primary endpoint is acute grade ≥4 toxicity within 6 months. Secondary endpoints include local control, toxicity profile, progression-free survival, time to ADT, and quality of life. A total of 48 patients will be included.
Rationale
Prostate cancer patients with oligorecurrent nodal relapse after curative treatment may benefit from metastasis-directed therapy to delay systemic treatment. Stereotactic ablative radiotherapy (SABR) is widely used, but typically delivered in 3-5 fractions. The introduction of MR-Linac technology allows for highly precise real-time targeting and adaptive planning, making single-fraction SABR a promising alternative. However, clinical data on safety and efficacy remain limited. This study investigates whether a single 24 Gy fraction delivered on MR-Linac is safe and well-tolerated, while also evaluating local control, quality of life, and time to systemic therapy.
Description of the cohort
The study will include 48 male patients with oligorecurrent prostate cancer presenting with pelvic or abdominal lymph node relapse after previous curative treatment (radical prostatectomy and/or radiotherapy). All participants are referred to the Department of Oncology, Odense University Hospital, and receive treatment as outpatients in the MR-Linac radiotherapy unit.
Data and biological material
No biological material will be collected. The study will include questionnaire data (quality of life and symptom burden), clinical data from the patient journal (age, comorbidity, PSA levels, imaging findings, treatment details, adverse events), and physician-assessed toxicity (CTCAE). Data on survival and disease progression will be collected from routine follow-up. No data will be retrieved from national registries.