Fusion target biopsy of the prostate using real-time ultrasound and MR images

Prostate cancer is the most common malignancy amongst men in the Netherlands,
with an incidence of 11.428 in 2011.
Transrectal ultrasound (TRUS) guided biopsy has a low sensitivity and
specificity for prostate cancer detection, due to the inability of grey-scale
ultrasonography to distinguish prostate cancer from benign prostate tissue.
Repeat biopsies after negative biopsy result show a high incidence of prostate
cancer. Consequently a delay of correct diagnosis and treatment occurs.
Development of new MRI techniques have boosted the sensitivity of imaging and
increased prostate cancer detection rates. Especially the development op
multiparametric (mp) MRI, which includes functional MRI techniques, has
contributed to this advancement. International guidelines recommend making a
mpMRI if biopsy results are negative but the clinical suspicion on prostate
cancer persists. The evaluation of mpMRI is complex and requires expertise by
the evaluating radiologist. A standardised method to evaluate mpMRI of the
prostate is by applying the PI-RADS classification system. Abnormalities on
mpMRI are evaluated using various modalities and graded on a scale of 1 to 5.
The higher the PI-RADS score, the higher the chance of malignancy.
Image guided biopsies are promising; a higher percentage pf significant
prostate cancer is found, using less biopsy cores. Nevertheless this technique
remains controversial due to impracticalities, such as low availability in the
Netherlands, and its time consuming and costly nature.
Recently fusion devices have been developed, combining the high sensitivity of
MRI for prostate cancer with the practicality of ultrasonography. Studies using
these devices show a increase in prostate cancer detection, using less biopsy
cores without the necessity to perform the biopsy procedure in the MRI suite.
Up to date no multicenter, randomised controlled studies have been executed.

To evaluate the clinical role of MRI/TRUS fusion target biopsy on prostate
cancer detection, compared with other target biopsy strategies, in men with a
persistent clinical suspicion on prostate cancer and at least one negative TRUS
guided biopsy session.

Histopathological validation of mpMRI imaging and PI-RADS classification
system.

Three-arm randomised controlled, multicentre trial with 2 sub-investigations.

Sub-investigation 1 consists of superiority study (fusion biopsy vs cognitive
biopsy) to demonstrate superiority of the study intervention compared to the
currently most applied technique.
Sub-investigation 2 consists of an equivalence study (fusion biopsy vs MRI
biopsy) to demonstrate non-inferiority of the intervention compared to the
currently best available technique.

Study intervention:
MRI/TRUS fusion target perineal prostate biopsy

Comparator interventions:
Cognitive TRUS target prostate biopsy
In-bore MRI target transrectal prostate biopsy

The nature and extent of burden associated with participation consists of 2
visits to the out-patient urology clinic, filling in three questionnaires
twice; undergoing MRI imaging of the prostate; and possibly undergoing a target
biopsy session of the prostate. An estimated 250 minutes per subject is
necessary to comlete participation of this investigation. (standard
diagnostics)
Risks of participation are ascribed to the undergoing of a target biopsy
session. Previously described physical risks include transient haematuria,
(febrile) urine tract infection, (exaggeration of) erectile dysfunction,
urinary retention, (exaggeration of) lower urinary tract symptoms, perineal
hematoma and for the comparator interventions also rectal bleeding.
Based on the currently available publications on target biopsy of the prostate
the risk of complications is estimated to be low.