Abstract
Objective
Transrectal ultrasound guided biopsy for diagnostic workup for prostate cancer (PCa)
has a substantial false negative rate. We sought to estimate PCa incidence and mortality
following negative biopsy in a cohort of men undergoing prostate cancer screening.
Subjects and Methods
The Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial randomized
participants 55-74 years to an intervention vs control arm. Intervention arm men received
annual prostate-specific antigen (PSA) tests for 6 years and digital rectal exams
(DRE) for 4 years. We examined the cohort of men with a positive PSA (> 4 ng/mL) or
DRE screen followed within one year by a negative biopsy. PCa incidence and mortality
rates from time of first negative biopsy were analyzed as a function of PSA level
at diagnosis and other factors. Cumulative incidence and mortality rates accounting
for competing risk were estimated. Multivariate proportional hazards regression was
utilized to estimate hazard ratios (HRs) of PCa outcomes by PSA level, controlling
for age and race.
Results
The negative biopsy cohort included 2855 men. Median (25th/75th) age at biopsy was
65 (61/69) years; biopsies occurred between 1994 and 2006. Median (25/75th) follow-up
was 13.2 (6.5/16.8) years for incidence and 16.6 (12.3/19.2) years for mortality.
740 PCa cases were diagnosed, with 33 PCa deaths. Overall 20-year cumulative PCa incidence
and mortality rates were 26.4% (95% CI: 24.8-28.1) and 1.2% (95% CI: 0.9-1.7), respectively.
HRs for PCa incidence and mortality increased significantly with increasing PSA.
Conclusion
The mortality rate from PCa through 20 years following a negative biopsy is low.
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Article info
Publication history
Published online: June 26, 2021
Accepted:
May 5,
2021
Received:
January 20,
2021
Footnotes
Financial Disclosure: The authors report no conflicts of interest.
Funding Support: Cancer incidence data have been provided by the following state cancer registries: Alabama, Arizona, California, Colorado, District of Columbia, Hawaii, Idaho, Maryland, Michigan, Minnesota, Missouri, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Wisconsin. All are supported in part by funds from the Centers for Disease Control and Prevention, National Program for Central Registries, local states, or by the National Cancer Institute, Surveillance, Epidemiology, and End Results Program. The results reported here and the conclusions derived are the sole responsibility of the authors.
HCA Disclaimer
This research was supported in part by HCA Healthcare and an HCA Healthcare affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities.
NIH Disclaimer
The content is solely the responsibility of the authors and does not necessarily represent the views of the National Institutes of Health.
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Access this article on ScienceDirectLinked Article
- Re: Dudith Pierre-Victor, Howard L. Parnes, Gerald L. Andriole, et al. Prostate Cancer Incidence and Mortality Following a Negative Biopsy in a Population Undergoing PSA Screening. Urology 2021 Jun 26;S0090-4295(21)00539-2UrologyVol. 156
- PreviewWe read with great interest the recent work of Pierre-Victor et al on prostate cancer incidence and mortality in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.1 We previously reported, in 2017, on a similar cohort from this trial.2 We studied men in the screening arm who screened positive (via prostate-specific antigen or digital rectal exam) during the first year of the trial, and whose linked biopsy was negative. We found a similar mortality rate after a median follow-up of 12.9 years of 1.1% (vs 1.2% in the present study).
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