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

NCT07635108 | Not Yet Recruiting DMC

• 2 other identifiers: OP-2499S-20250058
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

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; Metastasis-directed therapy; PSMA-PET/CT; Lymph node metastasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 6 months after completion of radiotherapy

Secondary Outcomes (9)

• Number of participants with late adverse events (CTCAE v5.0)

  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

  From radiotherapy until local progression or last follow-up, up to 5 years

• Median clinical progression-free survival

  From radiotherapy up to 5 years

• Median time to initiation of palliative ADT (ADT-free survival)

  From inclusion up to 5 years

• Number of participants with acute adverse events (CTCAE v5.0), by maximum grade

  Within 6 months after radiotherapy

Study Arms (1)

Single-fraction MR-guided SBRT

EXPERIMENTAL

All participants receive 24 Gy in a single fraction to the GTV, delivered with MR-guided SBRT.

Radiation: Single-fraction SBRT

Interventions

Single-fraction SBRT RADIATION

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

Single-fraction MR-guided SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Department of Oncology, Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kristine S Nielsen, MD

CONTACT

+45 31269894; kristine.skovly.nielsen@rsyd.dk

Tine Schytte, Professor

CONTACT

+45 21421114; tine-schytte@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): September 1, 2035
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)