Virtual biopsy for prostate cancer using PSMA PET and AI
Prostate Cancer Malignancy Grading Using Prostate Specific Membrane Antigen (PSMA) PET and Machine Learning
This project will try to use PSMA PET scans combined with machine learning to predict Gleason scores without invasive biopsies for men with suspected or diagnosed prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Sex | Male |
| Sponsor | University Hospital of North Norway Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tromsø, Troms) |
| Trial ID | NCT07266129 on ClinicalTrials.gov |
What this trial studies
The project combines early static and dynamic PSMA PET imaging with MRI, tracer kinetic modelling, and deep learning to predict tumor Gleason Score non-invasively. Imaging-derived biomarkers will be validated against ex-vivo cellular measures of PSMA internalization and conventional histopathology when available. The approach aims to provide full 3D assessment of the prostate and shorten diagnostic workflows. Data will be collected at a single center and used to train and validate predictive AI models.
Who should consider this trial
Good fit: Men referred for clinical PSMA PET or referred to a urologist for suspected prostate cancer based on symptoms or elevated PSA who meet imaging eligibility (including the listed weight and MRI-compatibility criteria and no prior prostatectomy) are the intended participants.
Not a fit: Patients who have had a prostatectomy, who are excluded due to body weight under 100 kg, or who cannot undergo MRI (MRI-incompatible implants) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this method could reduce the number of invasive biopsies, improve diagnostic accuracy, and speed up prostate cancer workups.
How similar studies have performed: Prior work shows PSMA PET can improve tumor localization and may correlate with aggressiveness, but using combined PET/MRI plus AI to non-invasively predict Gleason Score is relatively novel and still experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For patients who have undergone biopsies prior to PET: * Patients referred to clinical PET examination * For patients who have not had biopsies prior to PET: * Patients referred to urologist for suspected prostate cancer based on clinical symptoms or elevated PSA-levels Exclusion Criteria: * Prostatektomy * Body weight under 100 kg * MRI incompatible implants or other incompatibilities
Where this trial is running
Tromsø, Troms
- Universitetssykehuset Nord Norge, Tromsø — Tromsø, Troms, Norway (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.