Prognostic significance of a negative prostate biopsy: An analysis of subjects enrolled in a prostate cancer screening trial

The optimal management of patients following a negative prostate biopsy is unknown. Consequently, resources are increasingly being directed towards risk stratification within this cohort. However the risk of prostate cancer mortality in this group before introduction of supplemental biomarkers and imaging techniques is unclear.

The Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial provides survival data prior to implementation of new diagnostic interventions. We divided men with initial positive screen and subsequent prostate biopsy into cohorts on the basis of positive or negative results. Prostate cancer-specific mortality was then compared to the trial's control arm to estimate the prognostic significance of biopsy results relative to the general population.

36,525 and 36,560 patients comprised the screening and control arms, respectively. Of 4,064 subjects with a positive first screen, 1,233 underwent a linked biopsy; 473 were positive and 760 were negative. After median follow-up of 12.9 years, 1.1% of men in the negative biopsy cohort died of prostate cancer. The difference in mortality rate between negative biopsy and control arms was 0.734 deaths per 1000 person-years. Proportional sub-hazard ratios of prostate cancer specific mortality for negative biopsy and positive biopsy relative to the control arm were 2.93 (95% confidence interval [CI], 1.44-5.99) and 18.77 (95% CI, 12.62-27.93), respectively.

After a negative prostate biopsy, men face a relatively low risk of dying from prostate cancer when followed with traditional markers and biopsy techniques, suggesting limited potential for new diagnostic interventions to improve survival in this group.

The Journal of urology. 2016 Nov 08 [Epub ahead of print]

Patrick Lewicki, Jonathan Shoag, David M Golombos, Clara Oromendia, Karla V Ballman, Joshua A Halpern, Benjamin V Stone, Padraic O'Malley, Christopher E Barbieri, Douglas S Scherr

Department of Urology, Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY., Department of Urology, Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY. Electronic address: ., Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, NY.