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

June 11, 2026 updated by: Odense University Hospital

Improved MR-Guided Single-fraction Stereotactic Sblative Radiotherapy in Pelvic and Abdominal Nodal Oliorecurrent Prostate Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PINPOINT is a prospective, investigator-initiated, single-centre, single-arm phase 2 trial of single-fraction MR-guided SBRT in patients with nodal oligorecurrent prostate cancer. Eligible men have PSMA-PET/CT-verified nodal relapse in the pelvis or abdomen following curatively intended local treatment.

All patients are simulated with MRI in treatment position and treated with 24 Gy in 1 fraction to the gross tumour volume (GTV) using inverse-planned step-and-shoot IMRT on an MR-linac. No CTV margin is added (CTV = GTV); PTV margins account for motion and set-up uncertainty. Normal-tissue constraints are prioritised over target coverage.

The primary endpoint is cumulative CTCAE v5 grade ≥4 treatment-related toxicity within 6 months. Sample size follows a Simon two-stage design (H0: grade 4-5 TRAE rate 15%; H1: 4%; one-sided α = 5%, power 80%), with an interim analysis after 6-month follow-up of the first 16 patients and a total of 48 patients. Follow-up continues for 5 years. Toxicity (CTCAE v5), quality of life (EQ-5D-5L, EORTC QLQ-C30) and patient-reported outcomes (PRO-CTCAE) are collected at baseline and through follow-up; PSA and PSMA-PET/CT (on rising PSA) follow standard of care.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-fraction MR-guided SBRT
All participants receive 24 Gy in a single fraction to the GTV, delivered with MR-guided SBRT.
Radiation: Single-fraction SBRT
Participants will receive 24 Gy in 1 fraction to a lymph node.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events
Time Frame: 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.
Within 6 months after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with late adverse events (CTCAE v5.0)
Time Frame: 1, 1,5, 2, 3 and 5 years

The NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measures side-effect.

Possible scores range from 0-5, with higher scores indicating a worse outcome.
1, 1,5, 2, 3 and 5 years
Percentage of participants free from local progression (PSMA-PET/CT-verified), estimated by time-to-event analysis
Time Frame: From radiotherapy until local progression or last follow-up, up to 5 years
Defined as freedom from PSMA-verified relapse within the treated area. In the case of significant increase in PSA, a PSMA will be performed as to local guidelines. Local control will be evaluated at a lesion level, lesion by lesion. Within the treated area is defined as within or adjacent to the planning target volume (PTV).
From radiotherapy until local progression or last follow-up, up to 5 years
Median clinical progression-free survival
Time Frame: From radiotherapy up to 5 years
Defined as time from inclusion to any new node or distant metastases recurrence.
From radiotherapy up to 5 years
Median time to initiation of palliative ADT (ADT-free survival)
Time Frame: From inclusion up to 5 years
ADT-free survival is defined as the time from trial randomization to start of hormonal treatment
From inclusion up to 5 years
Number of participants with acute adverse events (CTCAE v5.0), by maximum grade
Time Frame: Within 6 months after 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.
Within 6 months after radiotherapy
Median overall survival
Time Frame: From inclusion up to 5 years
Overall survival is defined as time form inclusion to death from any cause
From inclusion up to 5 years
Mean change from baseline in EQ-5D-5L index (utility) score
Time Frame: Baseline, 2 weeks, 3,6 and 12 months
The EQ-5D-5L is a standardized, validated generic instrument for health-related quality of life. It comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels. Responses are converted to a single summary index (utility) score using a country-specific (Danish) value set, anchored at 1 = full health and 0 = death, with negative values possible for health states considered worse than death; higher scores indicate better health-related quality of life. The outcome is reported as the mean change from baseline in the EQ-5D-5L index score at each assessment time point.
Baseline, 2 weeks, 3,6 and 12 months
Mean change from baseline in EORTC QLQ-C30 Global Health Status / QoL scale score
Time Frame: Baseline, 2 weeks, 3, 6 and 12 months
The EORTC QLQ-C30 (version 3.0) is a validated cancer-specific questionnaire for assessing health-related quality of life in clinical trials. It contains 30 items comprising a global health status / quality of life scale, five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), and several single-item symptom and financial-impact measures. Raw scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual; for the global health status / QoL scale a higher score indicates better quality of life. This outcome is reported as the mean change from baseline in the global health status / QoL scale score at each assessment time point.
Baseline, 2 weeks, 3, 6 and 12 months
Number of participants reporting symptomatic adverse events as assessed by PRO-CTCAE
Time Frame: Baseline, 2 weeks, 3,6 and 12 months
PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) is a validated patient-reported measurement system developed by the NCI to capture symptomatic toxicity in cancer clinical trials. A predefined subset of PRO-CTCAE items is used in this trial. Each symptom is rated by the patient over the prior 7 days across the applicable attributes - frequency (never to almost constantly), severity (none to very severe), and/or interference with usual or daily activities (not at all to very much) - each on a 5-point ordinal scale (scored 0-4). The outcome is reported as the number of participants in each response category per item and attribute at each assessment time point.
Baseline, 2 weeks, 3,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Danish Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

September 1, 2035

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP-2499
  • S-20250058 (Other Identifier: Ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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