About this trial
With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.
Eligibility criteria
Qualifiers
willing to participate in the study by giving written informed consent.
male subjects aged between 50 to 75 years.
with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
good health condition based on medical history, physical examination and vital sign measurements.
Disqualifiers
has a prior history of prostate cancer.
had prior prostate biopsy.
has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
has evidence of lymph nodes involvement on prostate MRI or abdominal CT
Trial design
Treatments tested in this trial
- MRI-targeted prostate biopsy