Imaging for Significant Prostate Cancer Risk Evaluation

Summary

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.

Conditions

• Prostate Cancer

Interventions

PROCEDURE

Prostate HistoScanning

Advanced Ultrasound assessment of the prostate

PROCEDURE

Multi-parametric MRI

Multi-sequence Magnetic resonance imaging of the prostate

PROCEDURE

Transperineal prostate mapping biopsy

Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.

PROCEDURE

Image guided biopsies

Biopsies targeted to lesions seen at a) Prostate HistoScanning and b) mp-MRI. In men with an MRI lesion further MRI/US registration biopsies will be obtained

Sponsors & Collaborators

• Advanced Medical Diagnostics s.a.

  collaborator INDUSTRY

• University College London Hospitals

  lead OTHER

Principal Investigators

• Mark Emberton, MBBS,MD,FRCS · University College London Hospitals

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• United Kingdom

Study Locations