Open-label, Multi Center PET/CT Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY1075553 Following a Single Intravenous Administration of 300 MBq in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in 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.

Exclusion Criteria:

- Concurrent severe and/or uncontrolled and/or unstable medical disease other than
prostate cancer (e.g. poorly controlled diabetes, congestive heart failure,
myocardial infarction within 12 months prior to planned injection of BAY1075553,
unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe
pulmonary disease) which could compromise participation in the study

- Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or
occurring in the peri-operative liver transplantation period

- Active inflammatory bowel disease within the last 6 months

- Acute prostatitis requiring medical treatment within the last 6 months

- A non-urologic bacterial infection requiring active treatment with antibiotics
within 3 months

- Active other malignancy (except basal cell or squamous cell skin cancer) within the
last 2 years

- Patients with primary prostate cancer only: androgen ablation within 3 months before
planned treatment

- Subject fulfils criteria which in the opinion of the investigator preclude
participation for scientific reasons, for reasons of compliance, or for reasons of
the subject's safety