Risk stratification in men with a negative prostate biopsy: An interim analysis of a prospective cohort study

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OBJECTIVE: To investigate if a risk score for prostate cancer (PC) lifetime risk can be used to optimize triaging of patients with a negative prostate biopsy, but under sustained suspicion of PC.

METHODS AND PATIENTS: In this prospective clinical study, we included, and risk scored patients who had a cancer-negative transrectal ultrasound guided (TRUS) prostate biopsy, but elevated prostate specific antigen (PSA), a suspicious prostate digital rectal examination and/or a positive family history (FH) of PC. The risk score estimated individual lifetime risk of PC, based on a polygenic risk score (33 single nucleotide polymorphisms), age, and FH of PC. Patients were followed, under urologic supervision, for up to 4 years with annual controls, always including PSA measurements. Multiparametric magnetic resonance imaging (mpMRI) and/or prostate biopsy was performed at selected annual controls depending on risk score and at the urologist's/patient's discretion, which means that the follow-up differed based on the risk score.

RESULTS: We included 429 patients. After risk scoring, 376/429 (88%) patients were allocated to a normal-risk group (<30% PC lifetime risk) and 53/429 (12%) to a high-risk group (≥30% PC lifetime risk). The high-risk group had significantly different follow-up, with more biopsy and mpMRI sessions compared to the normal-risk group. PC was detected in 89/429 (21%) patients, with 67/376 (18%) patients diagnosed in the normal-risk group and 22/53 (42%) in the high-risk group. There was no statistically significant difference in the cumulative incidence of PC between the normal-risk group and the high-risk group after 4 years of follow-up. Currently, 67/429 (16%) patients are still being followed in this ongoing study.

CONCLUSION: In a 4-year perspective our PC lifetime risk score did not demonstrate significant prognostic value for triaging patients, with a negative TRUS-biopsy and sustained suspicion of PC.

TidsskriftBJU International
StatusE-pub ahead of print - 8 maj 2021

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