PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers

Inclusion Criteria

• •Part 1: Healthy volunteers only
• •\-- Males ≥ 40 years of age
• •Part 2: Prostate cancer patients
• •* Males ≥ 18 years of age
• •* Serum PSA (Prostate-Specific Antigen) value above normal.
• •* Patients had an MRI and/or a positive \[11C\] - or \[18F\] -choline PET/CT for primary diagnosis (Note: MRI and \[11C\]-or \[18F\]-choline PET/CT are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed
• •* Patients with primary prostate cancer have to be scheduled for prostatectomy
• •* In patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a Gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate
• •* Patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included
• •Part 3: Prostate cancer patients -- The criteria for eligibility of part 3 are identical to the ones of part 2. Except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.