MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT) (NCT07635108) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)
Denmark48 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a single-fraction SBRT approach guided by MRI to treat nodal recurrence of prostate cancer — how does delivering radiation in just one session compare to the multi-session approach I might get with standard treatment, and what does that mean for my situation?
2Since this trial is not yet recruiting, how long might it be before it opens, and is there a comparable trial or standard treatment option I should consider in the meantime rather than waiting?
3The trial's primary focus is measuring acute toxicity — meaning the main goal right now is understanding side effects, not proving the treatment works better — so what does that tell us about how much is already known about this approach's safety and effectiveness?
4My cancer has come back in the lymph nodes, which this trial specifically targets — can you help me understand whether my pattern of recurrence matches what this trial is looking for, and whether there are other options like salvage radiation or systemic therapy I should weigh against it?
5Because this trial is listed as Phase NA and is not yet recruiting, what would enrollment actually involve in terms of visits, follow-up appointments, and how the MRI-guided radiation would fit around my other treatments or daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events
Timeframe: Within 6 months after completion of radiotherapy