Predictors of Unfavourable Repeat Biopsy Results in Men Participating in a Prospective Active Surveillance Program

• Published in: European urology Vol. 61; no. 2; pp. 370 - 377
• Main Authors: Bul, Meelan, van den Bergh, Roderick C.N, Rannikko, Antti, Valdagni, Riccardo, Pickles, Tom, Bangma, Chris H, Roobol, Monique J
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier B.V 01.02.2012; Elsevier
• Subjects: Active surveillance; Aged; Biological and medical sciences; Biopsy; Disease progression; Gynecology. Andrology. Obstetrics; Humans; Male; Male genital diseases; Medical sciences; Middle Aged; Neoplasm Grading; Neoplasm Staging; Nephrology. Urinary tract diseases; Prognosis; Prostate-specific antigen; Prostate-Specific Antigen - blood; Prostatic neoplasms; Prostatic Neoplasms - blood; Prostatic Neoplasms - mortality; Prostatic Neoplasms - pathology; Reclassification; Risk; Tumors; Tumors of the urinary system; Urinary tract. Prostate gland; Urology; Active surveillance; Prostatic neoplasms; Biopsy; Prostate-specific antigen; Disease progression; Risk; Reclassification; Prostate tumor; Nephrology; Prognosis; Prostate disease; Disease; Male; Tumoral marker; Urology; Prostate specific antigen; Prospective; Adult; Evolution; Sanitary surveillance; Male genital diseases; Repetition; Human; Sanitary program; Urinary system disease; Anatomic pathology; Risk factor; Predictive factor
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2011.06.027

Abstract Background Active surveillance (AS) protocols for low-risk prostate cancer (PCa) generally include repeat prostate biopsies at predefined follow-up intervals. Objective To study the outcome of routinely obtained 1-yr repeat biopsies and factors predicting reclassification to higher risk, to contribute to risk stratification for men on AS. Design, setting, and participants We analysed men with low-risk PCa (clinical stage ≤T2, prostate-specific antigen (PSA) ≤10 ng/ml, PSA density <0.2 ng/ml per millilitre, one or two positive biopsy cores, and Gleason score ≤6) who had been included in a prospective AS protocol. Interventions PSA was measured 3-monthly and the first volume-dependent repeat biopsy was scheduled 1 yr after diagnosis, independent of PSA doubling time (PSA-DT). Reclassification to higher risk disease on repeat biopsy was defined as Gleason score ≥7 or ≥3 positive cores. Measurements We analysed whether baseline patient characteristics and PSA-DT were associated with reclassification to more aggressive PCa on repeat biopsy. Results and limitations A first repeat biopsy was taken in 757 patients after median follow-up of 1.03 yr. The results of repeat biopsies were favourable (no or low-risk PCa) in 594 patients (78.5%) and led to reclassification of risk in 163 (21.5%). Analysis showed that reclassification to higher risk was significantly influenced by the number of initial positive cores (two vs one) (odds ratio [OR]: 1.8; p = 0.002) and higher PSA density (OR: 2.1; p = 0.003). The outcome was not significantly influenced by age, clinical stage, total number of biopsy cores, or PSA. Adding PSA-DT at time of repeat biopsy to the model showed PSA-DT <3 yr to be significantly associated with reclassification to higher risk (OR: 1.7; p = 0.015). Data on tumour involvement per biopsy core were not available. Conclusions Clinical features at baseline and during follow-up in our AS cohort are significantly associated with short-term reclassification to higher risk on repeat biopsy. These characteristics can potentially be used for risk stratification of men with PCa who are apparently at favourable risk. Trial registration The current program is registered at the Dutch Trial Register with identification number ID NTR1718 ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1718 ).