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Shifting risk-stratified early prostate cancer detection to a primary healthcare setting.

BACKGROUND
The guidelines for Dutch general practitioners (GPs) recommend referring men with prostate-specific antigen (PSA) ≥3.0 ng/mL to secondary care for further clinical workup. This coincides with many referrals.


OBJECTIVE
To evaluate the feasibility of multivariable risk-stratification for early prostate cancer (PCa) detection in primary healthcare on the referral rate and subsequent PCa diagnoses.


PATIENTS AND METHODS
In 2014, Erasmus MC and the primary healthcare diagnostic facility STAR-SHL (location Rotterdam city center) started this observational study where GPs could refer men with a PCa screening wish to STAR-SHL for consultation by specially trained personnel. Referral recommendations to secondary healthcare were based on the outcome of the Rotterdam Prostate Cancer Risk Calculator (RPCRC). For data collection on PCa diagnoses, the study cohort was linked to the Dutch nationwide pathology databank (PALGA).


RESULTS
Between January 2014-February 2021, 507 men were referred for consultation and in 495 men PSA was tested. Median follow-up from consultation to PALGA linkage was 43 (interquartile range (IQR) 25-65) months. In total, 279 (56%) had PSA ≥3.0 ng/mL of which 68% (95% confidence interval (95%-CI) 63-74) were considered low-risk according to the RPCRC. Within 1 yr after consultation, one of these men (0.52%; 95%-CI 0.092-2.9) was diagnosed with clinically significant (cs)PCa (i.e. ISUP grade group ≥2). Thereafter, another four (2.1%; 95%-CI 0.82-5.3) low-risk men were diagnosed with csPCa. Among high-risk men who were biopsied within 1 yr after consultation (n=61), 77% (95%-CI 65-86) was diagnosed with PCa and 49% (95%-CI 37-61) with csPCa.


CONCLUSION
Multivariable risk-stratification for PCa detection using the RPCRC in a primary healthcare diagnostic facility could reduce 68% of referrals to secondary healthcare relative to the PSA threshold of 3.0 ng/mL with a high csPCa detection rate in those men biopsied. This strategy can be considered safe according to the observational data that showed low proportions of csPCa among men considered low-risk.