A GP’s blood test for prostate cancer—the PSA test—misses too many dangerous cancers and flags too many harmless ones, and this study will find out whether two newer tests do better in men who visit their doctor with symptoms. The problem is that over 80% of prostate cancer diagnoses start in primary care, yet the PSA test is unreliable. It can miss clinically significant cancers while triggering unnecessary referrals for men who turn out to have nothing wrong. Recent screening studies suggest that biparametric MRI (bpMRI) and a polygenic risk score (PRS) each outperform PSA, but no one has tested them head-to-head in symptomatic men—the very group GPs see every day. If bpMRI or PRS proves more accurate, GPs could use them to decide which men need an urgent cancer referral and which do not. That would reduce unnecessary biopsies and anxiety, while catching more dangerous cancers earlier. The results will directly inform NICE guidance and lay the groundwork for a larger trial on cost-effectiveness. For the 50,000 UK men diagnosed with prostate cancer each year, better triage in primary care could mean faster, more precise treatment pathways.
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Research question How does the diagnostic accuracy of biparametric magnetic resonance imaging (bpMRI) or a multi-ancestry prostate cancer polygenic risk score (PRS) compare to prostate specific antigen (PSA) for detecting clinically significant prostate cancer in symptomatic men presenting to primary care? Background Prostate cancer is the most common cancer in UK men, with over 50,000 new cases each year. The route to diagnosis for over 80% of men with prostate cancer starts in primary care with assessment of symptoms associated with prostate cancer, such as lower urinary tract symptoms (LUTS), or opportunistic, asymptomatic PSA testing. Recent screening test studies show that bpMRI or PRS each individually outperform PSA for detecting clinically significant prostate cancer. The diagnostic performance of these tests in symptomatic men and the downstream impacts on urgent suspected cancer referrals, treatments, and patient outcomes is unknown. Aims and objectives Primary aim = Compare the performance of PSA, bpMRI, or PRS as individual tests for detecting clinically significant prostate cancer in symptomatic men presenting in primary care. Secondary aim = Evaluate the optimal combination of tests for early-stage detection of clinically significant prostate cancer. Methods A fully paired prospective diagnostic cohort study will consecutively recruit 452 men aged 50-79 years (45-79 years for Black men or men with first-degree relative with prostate cancer) presenting to their GP with new onset LUTS or haematuria and no history of prostate cancer. Participant demographics, medical history, International Prostate Symptom Score, and body mass index will be collected. PSA, bpMRI, and PRS tests will be performed for all participants at community diagnostic centres. Index test results will be interpreted by clinicians blinded to other results. Abnormal results for at least one test will trigger referral on the urgent suspected prostate cancer diagnostic pathway for NHS diagnostic testing. Diagnostic accuracy for clinically significant prostate cancer (Gleason score 3+4=7 or higher) for each index test will be calculated using prostate biopsy as the reference standard. Timelines for delivery The prospective diagnostic cohort study will commence recruiting in Year 2 of the Fellowship and run for three years. Participant follow-up, analysis of prospectively collected data, summary reports of the main findings, and dissemination activities engaging cancer leaders, patients, and the public will be undertaken in the final two years. PPI activities and the training and development programme will run across the entire Fellowship. Anticipated impact and dissemination Fill an evidence gap identified by NICE on the true performance of PSA in symptomatic men. Inform updates to national guidance for GPs using PSA to detect clinically significant prostate cancer. New evidence for the performance of bpMRI and prostate cancer PRS in primary care will inform a future larger trial of new prostate cancer diagnostic pathways for symptomatic men to evaluate cost-effectiveness and implementation. A dissemination strategy will be co-produced with the public advisors, PPI panel, and collaborators to deliver a suite of targeted materials to engage with the academic and clinical communities, health service leaders, and the public. Key findings from the GP-TEST-PRO study will be shared widely in a range of formats to ensure accessibility and suit the target audiences.
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