Prostate Cancer Clinical Trial
Official title:
PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.
The incidence of prostate cancer is rising however the number of deaths from prostate cancer
is stable. Meaning the investigators are diagnosing many men with prostate cancer that will
not impact on their life. The rise in incidence is mainly due to increased use of the blood
test Prostate Specific Antigen (PSA), as a screening test.
Currently men suspected of having prostate cancer, identified by a raised PSA undergo
trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test
unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as
it is random and performed blind-the operator does not know where the cancer is. Thus many
low-risk cancers that do not need treating are diagnosed and many high risk cancers are
missed or incorrectly classified. So, men with a negative biopsy or those with low risk
disease are usually advised to undergo another TRUS biopsy.
An imaging test is needed that could help men and their doctors decide whether the biopsy is
a true reflection of what is inside his prostate.
The investigators will test the role of two imaging tests. The first, multi-parametric
magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The
second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the
results of these tests with a detailed biopsy map-transperineal template prostate mapping
biopsy (which is currently the best way to find out what is in the prostate but requires
multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone
one or more TRUS biopsies and who have been advised to have further tests on as part of
standard of care. They will be recruited from UCLH referral letters and clinics.
The investigators aim is to see if either of these tests can confidently rule out the
presence of clinically important disease.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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