Table 2 Inclusion and exclusion criteria

Inclusion criteria

 1. Men suspected localized PCA based on at least one of the following criteria:

  (a) Repeated PSA value ≥ 4 ng/ml

  (b) Suspicious palpation of the prostate on digital rectal examination

  (c) Tumor-suspicious findings on transrectal ultrasound

 2. Age ≥ 45 and < 76 years

 3. No previous prostate biopsy

 4. Ability to give written informed consent, participate in and comply with study

Exclusion criteria

 1. Allergy to the radiopharmaceutical 68 Ga-PSMA or to preparations with similar chemical structure

 2. Abuse of medications, drugs, or alcohol

 3. PSA level elevation > 100 ng/ml with resulting suspected advanced metastatic PCA

 4. Chronic ongoing severe renal disease defined by estimated creatinine clearance < 30 ml/min