Prostate CancerPINPOINTNCT07635108
MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)
A study testing Single-fraction SBRT in people with Prostate Cancer and Oligo-metastatic Prostate Carcinoma, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Oligo-metastatic Prostate Carcinoma, Oligometastatic Cancer
- What is being tested?
- Single-fraction SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2026to Sep 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Oncology, Odense University Hospital
Odense
Kristine S Nielsen, MD, +45 31269894, kristine.skovly.nielsen@rsyd.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Oligo-metastatic Prostate Carcinoma, Oligometastatic Cancer, Nodal Oligorecurrent Prostate Cancer
- Being tested
- Single-fraction SBRT
- Keywords
- Single-fraction SBRT, Nodal oligorecurrent prostate cancer, MR-guided SBRT, MR-Linac, Stereotactic body radiotherapy, Stereotactic ablative radiotherapy, Single-fraction radiotherapy, Oligometastasis / oligorecurrence, Metastasis-directed therapy, PSMA-PET/CT, Lymph node metastasis
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-fraction SBRTRadiation
Participants will receive 24 Gy in 1 fraction to a lymph node.
| Study group | Role | What they receive |
|---|---|---|
| Single-fraction MR-guided SBRT | Experimental | All participants receive 24 Gy in a single fraction to the GTV, delivered with MR-guided SBRT. Receives: Radiation: Single-fraction SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events
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.
Measured: Within 6 months after completion of radiotherapy
Secondary outcomes (9)
Number of participants with late adverse events (CTCAE v5.0)
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.
Measured: 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
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).
Measured: From radiotherapy until local progression or last follow-up, up to 5 years
Median clinical progression-free survival
Defined as time from inclusion to any new node or distant metastases recurrence.
Measured: From radiotherapy up to 5 years
Median time to initiation of palliative ADT (ADT-free survival)
ADT-free survival is defined as the time from trial randomization to start of hormonal treatment
Measured: From inclusion up to 5 years
Number of participants with acute adverse events (CTCAE v5.0), by maximum grade
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.
Measured: Within 6 months after radiotherapy
Median overall survival
Overall survival is defined as time form inclusion to death from any cause
Measured: From inclusion up to 5 years
Mean change from baseline in EQ-5D-5L index (utility) score
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.
Measured: Baseline, 2 weeks, 3,6 and 12 months
Mean change from baseline in EORTC QLQ-C30 Global Health Status / QoL scale score
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.
Measured: Baseline, 2 weeks, 3, 6 and 12 months
Number of participants reporting symptomatic adverse events as assessed by PRO-CTCAE
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.
Measured: Baseline, 2 weeks, 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635108
- Sponsor's protocol ID
- OP-2499
- Other IDs
- S-20250058
- Acronym
- PINPOINT
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved MR-Guided Single-fraction Stereotactic Sblative Radiotherapy in Pelvic and Abdominal Nodal Oliorecurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT07635108
- Acronym / sponsor ID
- PINPOINT / OP-2499
- Conditions
- Prostate Cancer, Oligo-metastatic Prostate Carcinoma, Oligometastatic Cancer, Nodal Oligorecurrent Prostate Cancer
- Keywords
- Single-fraction SBRT, Nodal oligorecurrent prostate cancer, MR-guided SBRT, MR-Linac, Stereotactic body radiotherapy, Stereotactic ablative radiotherapy, Single-fraction radiotherapy, Oligometastasis / oligorecurrence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-fraction MR-guided SBRT | Experimental | Radiation: Single-fraction SBRTAll participants receive 24 Gy in a single fraction to the GTV, delivered with MR-guided SBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-fraction SBRTParticipants will receive 24 Gy in 1 fraction to a lymph node. | Radiation | Single-fraction MR-guided SBRT |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-fraction SBRT in people with Prostate Cancer and Oligo-metastatic Prostate Carcinoma, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristine S Nielsen, MD (+45 31269894, kristine.skovly.nielsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events (time frame: Within 6 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.