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Active, Not Recruiting

NCT Number: NCT02562131

PET-MR-PSA Prostate Cancer Recidive Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Recurrent Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

St Olavs Hospital, PET center

Trondheim, 7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.

    Time frame: 10 years

    Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: PET-MR-PSA

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2015
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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