AI-based Measurements of Tumour Burden in PSMA PET-CT

NCT06363435 | Recruiting

• 1 other identifier: #2022-01302-02-PSMA
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence).

Conditions

Prostate Cancer

Keywords

artificial intelligence; 18F-PSMA-1007

Outcome Measures

Primary Outcomes (1)

• Tumour burden (cm3) in relation to overall survival

  Evaluate how the total tumour burden (cm3) predicts overall survival (OS). The total tumour burden will automatically be calculated by the AI-based method and will through Cox regression analysis be related to OS

  5-year follow-up

Secondary Outcomes (4)

• Tumour burden (cm3) in relation to biochemical recurrence

  5 years

• Number of tumours/metastases in relation to OS

  5 years

• Comparing two different segmentation methods in relation to OS

  5 years

• Comparing total tumour burden (cm3) measured manually and by the AI-based mehtod

  5 years

Study Arms (1)

Patients with prostate cancer

Patients referred to clinically indicated PSMA PET-CT due to initial or secondary staging of prostate cancer

Device: AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans

Interventions

AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans DEVICE

Tumour burden will be automatically calculated and stored in a database. The result of the AI-based measurements will not involve the handling of the patients

Patients with prostate cancer

Eligibility Criteria

• Age: 20 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who undergo PSMA PET-CT scans due to primary staging of high-risk prostate cancer or due to secondary staging due to biochemical recurrance of prostate cancer

You may qualify if:

• Patients referred to a clinically indicated 18F-PSMA-1007 PET-CT scan at Skåne University Hospital, Lund or Malmö, Sweden

You may not qualify if:

• Patients under 20 years old

Sponsors & Collaborators

• Elin Tragardh: lead
• Lund University: collaborator

Study Sites (2)

Skåne University Hospital

Lund, Sweden

RECRUITING

Skåne university hospital

Malmo, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Elin Tragardh, Prof

CONTACT

+4640338724; elin.tragardh@skane.se

Study Design

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

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 12, 2024
• Study Start: March 29, 2024
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2033
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)