title: Long-term follow-up of a large active surveillance cohort of patients with prostate cancer.
abstract: OBJECTIVE
  Active surveillance is increasingly accepted as a treatment option for favorable-risk prostate cancer. Long-term follow-up has been lacking. In this study, we report the long-term outcome of a large active surveillance protocol in men with favorable-risk prostate cancer.
  
  
  METHODS
  In a prospective single-arm cohort study carried out at a single academic health sciences center, 993 men with favorable- or intermediate-risk prostate cancer were managed with an initial expectant approach. Intervention was offered for a prostate-specific antigen (PSA) doubling time of less than 3 years, Gleason score progression, or unequivocal clinical progression. Main outcome measures were overall and disease-specific survival, rate of treatment, and PSA failure rate in the treated patients.
  
  
  RESULTS
  Among the 819 survivors, the median follow-up time from the first biopsy is 6.4 years (range, 0.2 to 19.8 years). One hundred forty-nine (15%) of 993 patients died, and 844 patients are alive (censored rate, 85.0%). There were 15 deaths (1.5%) from prostate cancer. The 10- and 15-year actuarial cause-specific survival rates were 98.1% and 94.3%, respectively. An additional 13 patients (1.3%) developed metastatic disease and are alive with confirmed metastases (n = 9) or have died of other causes (n = 4). At 5, 10, and 15 years, 75.7%, 63.5%, and 55.0% of patients remained untreated and on surveillance. The cumulative hazard ratio for nonprostate-to-prostate cancer mortality was 9.2:1.
  
  
  CONCLUSIONS
  Active surveillance for favorable-risk prostate cancer is feasible and seems safe in the 15-year time frame. In our cohort, 2.8% of patients have developed metastatic disease, and 1.5% have died of prostate cancer. This mortality rate is consistent with expected mortality in favorable-risk patients managed with initial definitive intervention.
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. Laurence.klotz@sunnybrook.ca.
authors.forename: Laurence
authors.initials: L
authors.lastname: Klotz
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Danny
authors.initials: D
authors.lastname: Vesprini
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Perakaa
authors.initials: P
authors.lastname: Sethukavalan
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Vibhuti
authors.initials: V
authors.lastname: Jethava
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Liying
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Suneil
authors.initials: S
authors.lastname: Jain
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Mamedov
authors.affiliation: Laurence Klotz, Danny Vesprini, Perakaa Sethukavalan, Vibhuti Jethava, Liying Zhang, Suneil Jain, Toshihiro Yamamoto, and Andrew Loblaw, Sunnybrook Health Sciences Centre, University of Toronto; and Alexandre Mamedov, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Loblaw
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood*; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D016017:Odds Ratio; D009864:Ontario / Q000453:epidemiology; D011159:Population Surveillance / Q000379:methods; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood / Q000401:mortality / Q000473:pathology / Q000628:therapy; D012307:Risk Factors; D013997:Time Factors; D057832:Watchful Waiting
chemical_list: D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen