PET-MR-PSA Prostate Cancer Recidive Study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02562131

Acronym

PET-MR-PSA

Enrollment

Registered

2015-09-29

Start date

2015-09-30

Completion date

2027-12-31

Last updated

2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Recurrent

Keywords

PET-MR, recidive, PET/MR imaging, 18F-Fluciclovine, radical treatment, recurrence

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Norway

Outcome results