Abstract
ObjectivesTo reduce unnecessary biopsies (Bx) in an opportunistic screening programme of prostate cancer. Material and methodsWe performed a prospective evaluation of PCA3 as a second-line biomarker in an opportunistic screening for prostate cancer (PCa). From September 2010 until September 2012, 2,366 men, aged 40–74 years and with >10 years life expectancy, were initially screened with PSA/digital rectal examination (DRE). Men with previous Bx or with recent urine infections were excluded. Men with abnormal DRE and/or PSA>3ng/ml were submitted for PCA3. All men with PCA3≥35 underwent an initial biopsy (IBx) —12cores—. Men with PCA3<35 were randomized 1:1 to either IBx or observation. Re-biopsy (16–18 cores) criteria were PSA increase>.5ng/ml at 4-6months or PSAv>.75ng/ml/year. ResultsWith a median follow-up (FU) of 10.1months, PCA3 was performed in 321/2366 men (13.57%), 289 at first visit and 32 during FU. All 110 PCA3+ men (34.3%) were biopsied and PCa was identified in 43 men in IBx (39.1%). In the randomized arm, 110 were observed and 101 underwent biopsy, finding 12 PCa (11.9%), showing a statistically significant reduction of PCa detection rate in this cohort (p<.001). Global PCa detection rates were 40.9% and 9.5% for the PCA3+ and PCA3− branches, respectively (p<.001). Area under the curve for PSA and PCA3 were .601 and .74, respectively. This is an ongoing prospective study limited by its short follow-up period and still limited enrolment. ConclusionsPCA3 as a second-line biomarker within an opportunistic dual screening protocol can potentially avoid 65.7% and 50.1% biopsies at first round and at median FU of 10.1months, respectively, just missing around 3.2% of high grade PCa.
Published Version
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