Virtual Biopsy of Prostate Cancer Using PSMA PET and AI

NCT07266129 | Recruiting

• 2 other identifiers: 2022/7352HNF1673-23
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the most common type of cancer in Norwegian men, but many tumors are slow-growing and do not require treatment. Today, MRI is good at detecting suspicious lesions, yet it cannot reliably distinguish aggressive tumors from low-grade ones. As a result, many men undergo repeated invasive biopsies. New PET tracers targeting PSMA improve tumor localization and may correlate with cancer aggressiveness, offering potential for better assessment. This project aims to develop a method to predict Gleason Score non-invasively by applying machine learning to PET and MRI data. The work involves early static and dynamic PSMA PET imaging, tracer kinetic modelling, deep learning, and validation of PET-based measurements of PSMA internalization using ex-vivo cellular methods. If successful, the project could reduce the number of biopsies, improve diagnostic accuracy, offer full 3D assessment of the prostate, shorten clinical workflows, and help identify patients who would benefit most from PSMA-based radioligand therapy.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Prostate Cancer; Artificial Intelligence; Positron Emission Tomography; Prostate Specific Membrane Antigen

Outcome Measures

Primary Outcomes (1)

• PET imaging

  Dynamic and static PET imaging of participants including blood samples

  4 hours

Study Arms (3)

Full length dynamic PET post biopsy

Patients who are scheduled for a static PET undergoes a full length 60-minute dynamic PET scan during the uptake time before the routine clinical investigation.

Short dynamic PET and early static PET post biopsy

Patients who are scheduled for a static PET undergoes a short 15-minute dynamic PET scan during the first part of the uptake time, followed by a static whole body PET scan, before the routine clinical investigation.

Short dynamic PET and early static PET before biopsies

Patients who have suspected but not biopsy confirmed prostate cancer will undergo whole body static PET.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary prostate cancer patients.

You may qualify if:

• 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

You may not qualify if:

• Prostatektomy
• Body weight under 100 kg
• MRI incompatible implants or other incompatibilities

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

Universitetssykehuset Nord Norge, Tromsø

Tromsø, Troms, 9019, Norway

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: June 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Will share data upon reasonable request.

Locations

NO (1)