PET/MRI in Patients With Suspected Prostate Cancer

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

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].

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborators: BSM Diagnostica GmbH Vienna; Siemens Healthcare GmbH
• Treatments: Gallium 68 PSMA-11

Criteria

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