Prostate Neoplasm Clinical Trial
Official title:
A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior Biopsy
This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy
compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each
participant will be randomly allocated to one of the biopsy tests.
We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers
than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS
biopsy.
The classical pathway for the diagnosis of prostate cancer is trans-rectal ultrasound guided
(TRUS) biopsy of the prostate following a raised PSA. This is currently the mainstay for
prostate cancer diagnosis in the majority of centres. It has many advantages and can be
performed routinely under local anaesthetic in an outpatient setting. However it does have
some limitations, including the over-diagnosis of insignificant cancer and the
under-diagnosis of significant cancer.
An alternative pathway for the diagnosis of prostate cancer in men with raised prostate
specific antigen (PSA) is to perform a multi-parametric MRI to localize cancer and to use
this information to influence conduct of a subsequent biopsy, known as an MRI-targeted
biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar amount
of clinically significant cancer to TRUS-biopsy but may have several advantages, for example
in reducing the number of men who require biopsy.
This randomized controlled trial aims to assess the detection rate of clinically significant
and clinically insignificant cancer of MRI-targeted biopsy compared to standard 12-core TRUS
biopsy in men referred with clinical suspicion of prostate cancer who have had no prior
prostate biopsy.
A 'clinically insignificant cancer' is cancer which is unlikely to progress or affect a man's
life expectancy and therefore does not warrant treatment. However when diagnosed with
insignificant cancer a large proportion of patients request treatment in case a more
significant cancer is present. A prostate cancer detection pathway that finds significant
cancers while avoiding the diagnosis of insignificant cancer is a major unmet need.
The potential implications of this trial include:
- A redefining of the prostate cancer diagnostic pathway
- A reduction in the number of patients undergoing prostate biopsy
- A reduction in the number of biopsy cores taken per patient
- A reduction in biopsy-related sepsis, pain and other side effects
- A reduction in the over-diagnosis of clinically insignificant prostate cancer
- A reduction of the economic burden of diagnosing and treating prostate cancer
;
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