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NCT Number: NCT07635108

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lymphatic Metastasis Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nodal Oligorecurrent Prostate Cancer Oligo-metastatic Prostate Carcinoma Oligometastatic Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-fraction SBRT

Radiation

Participants will receive 24 Gy in 1 fraction to a lymph node.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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

  5. 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.

  6. Median overall survival

    Time frame: From inclusion up to 5 years

    Overall survival is defined as time form inclusion to death from any cause

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristine S Nielsen, MD

CONTACT

[email protected]

+45 31269894

Tine Schytte, Professor

CONTACT

[email protected]

+45 21421114

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

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

Acronym: PINPOINT

Important dates

Study start
2026
Primary completion
2030
Study completion
2035
First posted
Jun 9, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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