Active surveillance (AS) is a first-line management option for low-risk prostate cancer (CaP) patients, but standardized regimens are lacking, including uniform protocols for surveillance prostate biopsy. We compared outcomes for two AS regimens that differ in whether or not a scheduled biopsy was performed in the absence of clinical progression.

Retrospective review was performed for 313 consecutive CaP patients at a National Comprehensive Cancer Network (NCCN) institute who were assigned prospectively to one of two AS biopsy regimens. N=149 patients underwent biopsy only for clinical concern (for cause only, FCO), while N=164 patients underwent for cause biopsy plus scheduled annual or biannual biopsy (scheduled plus for cause, S+FC). Times to biopsy, clinical progression, pathologic reclassification and treatment were compared using Kaplan-Meier methodology.

FCO and S+FC groups were similar in NCCN risk category at AS initiation. Median follow-up was 48 and 38 months, respectively. No significant difference was observed in PSA dynamics or clinical progression rates, but S+FC patients had significantly more frequent biopsies (p<0.001), biopsy-related complications (p=0.04), pathologic reclassification (p=0.02) and treatment conversion (p=0.001). Adverse prostatectomy pathology (>/=pT3 and/or Gleason primary pattern 4) and early metastasis events were rare in both groups.

Omission of a scheduled biopsy during AS is associated with decreased biopsy burden and treatment conversion. Although no increase in adverse pathology or early metastasis was observed in this study, longer follow-up in larger cohorts is necessary to determine the impact of scheduled biopsy omission on these adverse outcomes.