Men with a raised PSA level currently face a needle biopsy that is both uncomfortable and often unnecessary. This trial, called PROMIS, will test whether a multi-parametric MRI scan can reliably rule out clinically significant prostate cancer, allowing some men to safely skip the biopsy altogether. The problem is that the standard transrectal ultrasound-guided biopsy misses around one in five significant cancers and frequently detects harmless ones, leading to overdiagnosis and overtreatment. The current pathway also causes anxiety, pain, and risk of infection for thousands of men each year. PROMIS will compare the accuracy of MRI against a more thorough reference standard—template prostate mapping biopsy under anaesthetic—to establish whether an MRI-first approach can improve detection of dangerous cancers while reducing unnecessary procedures. If MRI proves accurate enough, the NHS could adopt a new diagnostic pathway: men with raised PSA would first have an MRI, and only those with suspicious scans would proceed to biopsy. This would spare many men an invasive procedure, reduce healthcare costs, and improve quality of life by cutting overdiagnosis. The study will also model the cost-effectiveness of such a change, helping commissioners decide whether to roll it out nationally.
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At present, men with raised serum prostate specific antigen (PSA) are advised to have a transrectal ultrasound (TRUS) guided biopsy. This study will investigate whether imaging prior to biopsy can be incorporated into the existing diagnostic pathway for prostate cancer. We will evaluate whether men with a raised PSA, or other risk factors for harbouring prostate cancer, should first undergo a MP-MRI in order to select a group that could safely forego prostate biopsy. In addition, this study will evaluate the ability of MP-MRI to identify lesions for selective biopsy. In order to evaluate the diagnostic accuracy of MP-MRI (index test) against the TRUS guided biopsy (current standard test) both procedures need to be compared to a reference standard. This reference standard needs to be accurate at both detecting and ruling-out prostate cancer and amenable to application to all men at risk. Template Prostate Mapping (TPM) meets the necessary performance characteristics of such a reference test. It is performed under a general/spinal anaesthetic. By design, PROMIS, conforms to a validating paired cohort study (see Oxford Centre for Evidence-based Medicine, 'Levels of Evidence', 1b, http://www.cebm.net/index.aspx?o=1025). All men in the study will have a MP-MRI (index test), followed by both a TPM biopsy (reference test) and a standard TRUS guided biopsy (current standard test). These 3 tests will be assessed and reported independently from each other. The main objectives of the trial are: To assess the ability of MP-MRI to identify men who can safely avoid unnecessary biopsy. To assess the ability of the MP-MRI based pathway to improve the rate of detection of clinically significant cancer as compared to TRUS biopsy. To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway. Using data from the main study and the wider literature, the study will consider the implications of alternative diagnostic strategies for NHS cost and men's quality-adjusted survival duration.
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