PET-MR-PSA Prostate Cancer Recidive Study (PET-MR-PSA)

18F-Fluciclovine PET/MRI for Detection of Recurrent Prostate Cancer After Radical Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer Recurrent

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • St Olavs Hospital, PET center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The aim in 2 years is 80 prostate cancer patients with biochemical relapse following radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: CASE_ONLY
• Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Principal Investigator: Tone F Bathen, PhD, The Norwegian University of Science and Technology (NTNU)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimated): September 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 2, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: recurrence; PET-MR; 18F-Fluciclovine; recidive; PET/MR imaging; radical treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: 2015/163-4