MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)
NCT07635108 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-06-15
Summary
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
- Prostate Cancer
- Oligo-metastatic Prostate Carcinoma
- Oligometastatic Cancer
- Nodal Oligorecurrent Prostate Cancer
Interventions
- RADIATION
-
Single-fraction SBRT
Participants will receive 24 Gy in 1 fraction to a lymph node.
Sponsors & Collaborators
-
Danish Cancer Society
collaborator OTHER -
Odense University Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2030-04-30
- Completion
- 2035-09-30
Countries
- Denmark
Study Locations
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