Magnetic Resonance Imaging (MRI) improves the detection of clinically significant prostate cancer (PCa) by guiding biopsies of MRI-visible lesions (targeted biopsies) in patients suspected with having PCa. This strategy increases the detection of clinically significant PCa, however, while also increasing the detection of insignificant prostate cancer, often synonymous of "overdiagnosis".
It is well known that insignificant PCa has a very low risk of local and distant progression, and active surveillance with a deferred curative treatment protocol based on clear indicators of disease progression is now recommended for all insignificant PCa. However, higher detection of insignificant PCa can lead to patient anxiety about inclusion in an active surveillance protocol, potential further damage from repeated surveillance biopsies and higher healthcare costs.
Thus, there is a need for a new biopsy scheme that maintains clinically significant PCa's detection while reducing the diagnosis of insignificant PCa. In recent years, an alternative approach has been to add additional cores close to the target lesion, this is defined as regional biopsies. The hypothesis is that most clinically significant PCa missed in the target are found close to the target. Whereas most cancers found on systematic biopsies outside the MRI target probably correspond to insignificant PCa. This strategy aims to maintain the detection of clinically significant PCa, while reducing the detection of insignificant PCa.
This proposed multicenter diagnostic study aims to demonstrate the effectiveness of the experimental biopsy scheme (targeted + regional) in detecting clinically significant PCa, compared with a conventional scheme (targeted + systematic). We also aim to compare the detection of insignificant PCa by both schemes.
Adult men (≥ 18 years old)
Clinical suspicion of PCa (based on digital rectal examination, family history, PSA and PSA density values) and prescribed prostate biopsy
Detection by multi-parametric MRI of the prostate of a PI-RADS 4 or 5 index lesion, or a PI-RADS 3 index lesion with a PSA density ≥ 0.15 ng/ml/cc
Patient eligible for prostate biopsy under local or general anesthesia
History of prostate cancer
History of negative prostate biopsy
MRI negative (PI-RADS 1 or 2) or equivocal (PI-RADS 3) with PSA density < 0.15 ng/ml/cc
Patient unable to understand the terms of the study or unable to give informed consent (neurological or psychiatric disorders, non-French speaker, etc.)
Single group
Prostate biopsy
Procedure/SurgeryThe intervention for this study will be a modification of the standard prostate biopsy scheme. Instead of a targeted + systematic biopsy (3 targeted and 12 systematic biopsies (6 in each lobe)), the following 15 biopsies will be performed: * 3 targeted biopsies * 4 regional biopsies * 8 systematic biopsies (2 posterior right, 2 lateral right, 2 posterior left, 2 lateral left)
Sensitivity and specificity of the targeted + regional biopsy scheme for the detection of clinically significant prostate cancer
The primary endpoint is the sensitivity and specificity of the targeted + regional biopsy scheme for the detection of clinically significant PCa (ISUP grade group ≥ 2) compared to the sensitivity and specificity of the targeted + systematic biopsy scheme (standard of care). A biopsy will be considered negative if there is no cancer or only insignificant PCa (ISUP grade 1 group) detected. A biopsy will be considered positive if there is clinically significant PCa (ISUP grade ≥ 2 group) detected.
Detection of not significant prostate cancer
Difference in the detection rate of insignificant PCa (ISUP grade group 1) depending on the biopsy scheme (experimental vs standard)
Detection of agressive prostate cancer
Difference in the detection rate of aggressive PCa (ISUP grade group ≥ 3) depending on the biopsy scheme (experimental vs standard)
Creation of a nomogram for the detection of clinically significant prostate cancer
The endpoint of the nomogram is the detection of clinically significant PCa using a targeted + regional biopsy scheme
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