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Clinical Trials in Denmark / NCT07635108
Starting soon Not applicable

MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)

NCT07635108 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-15

Condition(s) studied

Prostate CancerOligo-metastatic Prostate CarcinomaOligometastatic CancerNodal Oligorecurrent Prostate Cancer

Investigational drug(s) / intervention(s)

Single-fraction SBRT

Single-fraction SBRT: Participants will receive 24 Gy in 1 fraction to a lymph node.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events — Within 6 months after completion of radiotherapy
    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.

Trial sites (1)

FacilityCityRegionStatus
Department of Oncology, Odense University Hospital Odense Denmark

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Other trials for the same condition

Phase III Radium 223 mCRPC-PEACE III Active, not recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort Active, not recruiting
The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice Active, not recruiting
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07635108 on ClinicalTrials.gov ↗ ← All trials in Denmark