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


CONCLUSIONS
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.
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD.
Jeffrey J
JJ
Tosoian
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD.
Mufaddal
M
Mamawala
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD.
Jonathan I
JI
Epstein
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD.
Patricia
P
Landis
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD.
Sacha
S
Wolf
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD.
Bruce J
BJ
Trock
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD. hcarter@jhmi.edu.
H Ballentine
HB
Carter
D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000453:epidemiology* / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D012307:Risk Factors; D018571:Sentinel Surveillance; D014481:United States / Q000453:epidemiology; D057832:Watchful Waiting