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.
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.
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
Single group
MRI-targeted prostate biopsy
Procedure/SurgeryAll participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)
Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer
Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference.
Analysis of the performance of software versus visual registration biopsy in subgroups
Assessment of the performance of software registration biopsy and visual registration biopsy in the detection of clinically significant cancer in : * lesions in small volume prostates (\<50 gram) versus large volume prostates (\>50 gram). * transitional zone versus peripheral zone lesions * basal versus apical lesions * small (max. diameter \< or = 10 mm) versus large lesions (max. diameter \> 10 mm) * intermediate suspicious lesions (PI-RADS 3) versus highly suspicious lesions (PI-RADS 4-5).
Added value of systematic biopsies
Assessment of the added value of systematic biopsies on top of MRI-targeted biopsy of PI-RADS 3, 4 and 5 lesions. Compare MRI-targeted + systematic biopsies versus MRI-targeted biopsies alone in T-staging and therapy options.
Discriminative features of PI-RADS 3 lesions on MRI
Lesion diameters, shape, intensity on T2 and aspect, ADC-values on ADC-map will be measured to identify possible discriminative features of 'malignant' s "benigne" PI-RADS 3 lesions.
Features of prostate cancer differentiation grade on MRI
Measure ADC-value to differentiate prostate cancer differentiation grade.
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