PET-MR-PSA Prostate Cancer Recidive Study

Active, not recruiting

• Conditions: Prostate Cancer Recurrent

• Registration Number: NCT02562131
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. The aim of this study is to evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for detection of recurrent prostate cancer.

Detailed Description

The patients follow standard treatment and follow-up after the PET/MRI exam, which will be determined by the patient's treating urologist and/or oncologist. Data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. The imaging findings will be compared with the reference standard to assess the sensitivity and specificity. The diagnostic accuracy of combined PET/MRI and MRI-only (the current clinical standard) will be compared.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• the criteria for biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer must be fulfilled (two consecutive measurements with PSA > 0.2 ng/ml following radical prostatectomy or PSA > 2.0 ng/ml above the nadir following definitive radiotherapy)
• potential candidates for salvage treatment based on age and co-morbidity.

Exclusion Criteria

• general contra-indications for a PET/MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
• impaired renal function defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.	10 years	Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan.

Trial Locations

Locations (1)

St Olavs Hospital, PET center; 🇳🇴 Trondheim, Norway