Intermediate and Longer-Term Outcomes From a Prospective Active-Surveillance Program for Favorable-Risk Prostate Cancer

Abstract

Purpose To assess long-term outcomes of men with favorable-risk prostate cancer in a prospective, active-surveillance program. Methods Curative intervention was recommended for disease reclassification to higher cancer grade or volume on prostate biopsy. Primary outcomes were overall, cancer-specific, and metastasis-free survival. Secondary outcomes were the cumulative incidence of reclassification and curative intervention. Factors associated with grade reclassification and curative intervention were evaluated in a Cox proportional hazards model. Results A total of 1,298 men (median age, 66 years) with a median follow-up of 5 years (range, 0.01 to 18.00 years) contributed 6,766 person-years of follow-up since 1995. Overall, cancer-specific, and metastasis-free survival rates were 93%, 99.9%, and 99.4%, respectively, at 10 years and 69%, 99.9%, and 99.4%, respectively, at 15 years. The cumulative incidence of grade reclassification was 26% at 10 years and was 31% at 15 years; cumulative incidence of curative intervention was 50% at 10 years and was 57% at 15 years. The median treatment-free survival was 8.5 years (range, 0.01 to 18 years). Factors associated with grade reclassification were older age (hazard ratio [HR], 1.03 for each additional year; 95% CI, 1.01 to 1.06), prostate-specific antigen density (HR, 1.21 per 0.1 unit increase; 95% CI, 1.12 to 1.46), and greater number of positive biopsy cores (HR, 1.47 for each additional positive core; 95% CI, 1.26 to 1.69). Factors associated with intervention were prostate-specific antigen density (HR, 1.38 per 0.1 unit increase; 95% CI, 1.22 to 1.56) and a greater number of positive biopsy cores (HR, 1.35 for one additional positive core; 95% CI, 1.19 to 1.53). Conclusion Men with favorable-risk prostate cancer should be informed of the low likelihood of harm from their diagnosis and should be encouraged to consider surveillance rather than curative intervention.

10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer

“…27 Active surveillance in such cohorts over a period of 15 years has yielded a disease-specific mortality of 0.1 to 1.5%, depending on the definition of low-risk or very-low-risk disease. 24,25 However, there remains little consensus about the best protocols for following these patients safely, in order to maintain them in a "window of curability." 28 In the ProtecT active-monitoring group, almost half the men received no intervention during the 10-year follow-up period.…”

“…Rates of change of management in the ProtecT trial were similar to those in other active surveillance programs. [24][25][26] Between-group comparisons with respect to disease progression should also be interpreted carefully because of different definitions and methods of ascertainment. In the surgery group, extracapsular extension (pT3 disease) was present in 29% of the men at the time of surgery, a proportion of whom could have been cured by the radical intervention.…”

Active Surveillance of Prostate Cancer: Use, Outcomes, Imaging, and Diagnostic Tools

“…4–6 In the United States, as of 2006, only 10% of low-risk prostate cancer were managed conservatively. 23 Since that time, however, there has been a major expansion in use.…”

“…6 This program aims to enroll very low-risk patients with a PSA density <0.15, clinical stage T1c, and Gleason score ≤6 in a maximum of 2 cores with ≤50% cancer involvement in any core. The protocol includes PSA and digital rectal examination (DRE) every 6 months and yearly prostate biopsy.…”

“…3,4 Observations from two large, prospective AS cohorts reach nearly 20 years of follow-up and indicate very low likelihood of metastatic disease or prostate cancer-specific mortality in appropriately selected men. 5,6 Despite its utility in reducing overtreatment, AS is not without morbidity. 7 The contemporary practice of AS remains largely based upon frequent clinical examination, serum prostate-specific antigen (PSA) testing, and prostate biopsy, 8 a procedure associated with patient discomfort and serious complications including infection.…”