PET-MR-PSA Prostate Cancer Recidive Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer Recurrent

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No