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Candidates for a prostate cancer screening clinical trial are needed.

UCL are looking for willing participants to take part in a new clinical trial testing prostate cancer screening methods.

The method being tested is PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.

The number of men being diagnosed with prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning many men are being diagnosed with prostate cancer that will not impact on their life. The explanation for this rise in incidence is partly due to increased use of the PSA test (Prostate Specific Antigen blood test), as a screening method.

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’ with the operator not knowing 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.

We, at the Prostate Cancer Research Centre, believe 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.

Researchers 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 results of these tests will be compared 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.)

Our aim is to see if either of these tests can confidently rule out the presence of clinically important disease.

Eligible men for this clinical trial will have undergone one or more TRUS biopsies and who are seeking further investigation/re-assurance regarding their disease status. 

Below are the Inclusion/Exclusion criteria:

Inclusion Criteria:

• Men who have undergone prior trans-rectal biopsies.
• Men seeking further evaluation of their prostate and who are suitable for characterisation using Transperineal Template Prostate Mapping Biopsy.

Exclusion Criteria:

• Previous history of ANY prostate cancer treatment
• Men unable to have MRI scan, or in whom artefact would reduce quality of MRI.
• Men unable to have general or regional anaesthesia
• Men unable to give informed consent

It is a trial best suited to men on Active surveillance who wish to reassure themselves that any significant disease in their prostate is not being missed, any man who is considering focal therapy for their prostate cancer which requires a high degree of confidence regarding disease status. Also men who have had repeated negative TRUS biopsies in the face of a high PSA and wish to ensure that we are not missing any disease within their prostate.

We are just awaiting final registration on www.clinicaltrials.gov and final Research and development approval and hope to be running early in 2012. We would be happy for any man who wishes to be considered to contact me to discuss eligibility. If eligible they would require their GP to refer them to UCLH for us to arrange an appointment for them.  The details for referral would be:

Professor Mark Emberton, MBBS,MD,FRCS
Study Principal Investigator
University College London Hospitals

250 Euston Road
London 
NW1 2PG

Alternative Contact:  

Trial Co-ordinator  Miss Lucy AM Simmons, MBBS, MRCS    

Telephone:   0044 203 447 9194
Email:   lucy.simmons@uclh.nhs.uk