Clinical validation of transrectal multiparametric ultrasound imaging strategy (PCaVision) for the detection of clinically significant prostate cancer: a European head-to-head comparison with the MRI-based strategy in primary diagnosis and in an active surveillance population

Current imaging techniques for the detection and grading of prostate cancer are
imperfect, which can lead to unnecessary biopsies, suboptimal treatment, and
missed clinically significant cancers. We hypothesize that computer analysis
(PCaVision) of 3D multiparametric ultrasound can accurately detect, localize,
and assess the aggressiveness of prostate cancer. 3D multiparametric ultrasound
could provide a more cost-effective and streamlined imaging technique compared
to the current standard: MRI.

The primary objective is to demonstrate non-inferiority of the detection rate
of clinically significant prostate cancer (defined as GG>=2) in targeted
biopsies based on PGaVision imaging (PCaVision pathway) in comparison with the
detection rate of clinically significant cancer in targeted biopsies based on
MRI (MRI pathway).

This study is a prospective, multicenter diagnostic accuracy study with a fully
paired design in men suspected of prostate cancer.
In summary, all patients will undergo imaging using MRI and PCaVision during
which suspicious lesions will be identified based on each imaging technique
independently with readers being blinded for the results of the other imaging
technique. In addition, biopsies can be performed. What biopsie strategy is
performed is based on the imaging results and local standard of care. In case
of a suspect lesion on imaging targeted biopsies will be performed. Local
standard might dictate that these targeted biopsies are supplemented by
systematic biopsies, this won't be part of the study protocol. In case of
negative imaging, biopsies can be omitted or systematic biopsies can be
performed. This also depends on the local standard of care and is not part of
the study protocol.
MRI targeted 3-core biopsy per lesion (maximum of 2 lesions) and/or a PCaVision
targeted 3-core biopsy (maximum of 2 lesions) will be performed by a second
physician if suspicious lesions have been identified based on imaging. lf
lesions have been identified with both PCaVision and MRI in the same patient,
the order of the targeted biopsies will be randomized. Histological examination
of targeted biopsies will be performed to determine presence of clinically
significant prostate cancer.

All patients undergo 3D mpUS using PcaVision and MRI. Suspicious lesions will
be identified based on each imaging technique independently. This will be
followed by a single biopsy session in which the following types of biopsies
might be performed.
hat biopsie strategy is performed is based on the imaging results and local
standard of care. In case of a suspect lesion on imaging targeted biopsies will
be performed. Local standard might dictate that these targeted biopsies are
supplemented by systematic biopsies, this won't be part of the study protocol.
In case of negative imaging, biopsies can be omitted or systematic biopsies can
be performed. This also depends on the local standard of care and is not part
of the study protocol.
A MRI targeted biopsy and/or a PCaVision targeted biopsy will be performed if
suspicious lesions have been identified based on imaging. Per imaging
technique, the following approach is followed. When 1 suspicious lesion has
been identified, 3 targeted biopsies will be taken. When 2 lesions have been
identified, 3 targeted biopsies will be taken per lesion, so 6 biopsies in
total. In case 3 or more suspicious lesions have been found, 2 lesions will be
selected based on: (1) PI-RADS and (2) size for MRI, and (1) severity
indication and (2) size for PCaVision. Consecutively, 3 targeted biopsies will
be taken from these 2 selected lesions.
So, the maximum number of targeted biopsies per imaging technique is 6, and the
maximum number of biopsies per patient is 24 including 12 systematic biopsies.
lf lesions have been identified with both PCaVision and MRI in the same
patient, the order of the targeted biopsies will be randomized. All biopsies
(systematic and targeted) will be performed in a single session.

- Possible additional hospital visit as for recording the 3D mpUS
- There is a small risk associated with the use of ultrasound contrast medium
for participants. After using contrast medium in millions of patients in
various types of ultrasound examinations, side effects appear to be rare and
mostly mild. Possible side effects are: change in taste, local pain at the
injection site and erythema of the face or body. In some cases, an allergie
reaction has been described, which is usually mild.
- Doing a 3D mpUS can lead to taking extra prostate biopsies