CompletedPhase 3

PET/MRI in Patients With Suspected Prostate Cancer

Austria220 participantsStarted 2016-01

Plain-language summary

This diagnostic clinical trial will be conducted according to a randomized, prospective, controlled, double-arm, single-centre design. The control will be implemented by comparing the PET/MRI results with the histopathological finding after radical prostatectomy (positive state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and standard biopsy are negative (negative state) and/or the detection of a biochemical tumor relapse \[rising prostate specific antigen (PSA) after PSA nadir; secondary objective\].

Who can participate

SexMALE

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Inclusion Criteria: * blood PSA level \> 4.0 ng/ml and * free-to-total PSA ratio \<22% and/or * progressive rise of PSA levels in two consecutive blood samples despite antibiotics Exclusion Criteria: * antiandrogen therapy * prostate needle biopsy \<21 days before PET/MRI * known active secondary cancer * endorectal coil not applicable (e.g. anus praetor with short rectal stump) * known active prostatitis (e.g. painful DRE) * known anaphylaxis against gadolinium-DOTA * patient's written informed consent not given * needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry

What they're measuring

Superiority of image guided biopsy using multiparametric metabolic hybrid imaging with FEC/PSMA-PET/MRI (Fluorethylcholin/Prostate Specific Membrane Antigen- PET/MRI)

Timeframe: 36 months

Trial details

NCT IDNCT02659527

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05

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