MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-fraction SBRT.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Oligo-metastatic Prostate Carcinoma, Oligometastatic Cancer, Nodal Oligorecurrent Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improved MR-Guided Single-fraction Stereotactic Sblative Radiotherapy in Pelvic and Abdominal Nodal Oliorecurrent Prostate Cancer
Overview
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.
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.
Interventions
- Radiation Single-fraction SBRT
Participants will receive 24 Gy in 1 fraction to a lymph node.
Primary outcome measures
- Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events [Time frame: Within 6 months after completion of radiotherapy]
Secondary outcome measures (9)
- Number of participants with late adverse events (CTCAE v5.0) [Time frame: 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]
- Median clinical progression-free survival [Time frame: From radiotherapy up to 5 years]
- Median time to initiation of palliative ADT (ADT-free survival) [Time frame: 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]
- Median overall survival [Time frame: 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]
- Mean change from baseline in EORTC QLQ-C30 Global Health Status / QoL scale score [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Oncology, Odense University Hospital — Odense
Identifiers
NCT: NCT07635108 · OP-2499 · S-20250058