Association Between Radiation Therapy, Surgery, or Observation for Localized Prostate Cancer and Patient-Reported Outcomes After 3 Years.
Understanding the adverse effects of contemporary approaches to localized prostate cancer treatment could inform shared decision making.



To compare functional outcomes and adverse effects associated with radical prostatectomy, external beam radiation therapy (EBRT), and active surveillance.



Prospective, population-based, cohort study involving 2550 men (≤80 years) diagnosed in 2011-2012 with clinical stage cT1-2, localized prostate cancer, with prostate-specific antigen levels less than 50 ng/mL, and enrolled within 6 months of diagnosis.



Treatment with radical prostatectomy, EBRT, or active surveillance was ascertained within 1 year of diagnosis.



Patient-reported function on the 26-item Expanded Prostate Cancer Index Composite (EPIC) 36 months after enrollment. Higher domain scores (range, 0-100) indicate better function. Minimum clinically important difference was defined as 10 to 12 points for sexual function, 6 for urinary incontinence, 5 for urinary irritative symptoms, 5 for bowel function, and 4 for hormonal function.



The cohort included 2550 men (mean age, 63.8 years; 74% white, 55% had intermediate- or high-risk disease), of whom 1523 (59.7%) underwent radical prostatectomy, 598 (23.5%) EBRT, and 429 (16.8%) active surveillance. Men in the EBRT group were older (mean age, 68.1 years vs 61.5 years, P < .001) and had worse baseline sexual function (mean score, 52.3 vs 65.2, P < .001) than men in the radical prostatectomy group. At 3 years, the adjusted mean sexual domain score for radical prostatectomy decreased more than for EBRT (mean difference, -11.9 points; 95% CI, -15.1 to -8.7). The decline in sexual domain scores between EBRT and active surveillance was not clinically significant (-4.3 points; 95% CI, -9.2 to 0.7). Radical prostatectomy was associated with worse urinary incontinence than EBRT (-18.0 points; 95% CI, -20.5 to -15.4) and active surveillance (-12.7 points; 95% CI, -16.0 to -9.3) but was associated with better urinary irritative symptoms than active surveillance (5.2 points; 95% CI, 3.2 to 7.2). No clinically significant differences for bowel or hormone function were noted beyond 12 months. No differences in health-related quality of life or disease-specific survival (3 deaths) were noted (99.7%-100%).



In this cohort of men with localized prostate cancer, radical prostatectomy was associated with a greater decrease in sexual function and urinary incontinence than either EBRT or active surveillance after 3 years and was associated with fewer urinary irritative symptoms than active surveillance; however, no meaningful differences existed in either bowel or hormonal function beyond 12 months or in in other domains of health-related quality-of-life measures. These findings may facilitate counseling regarding the comparative harms of contemporary treatments for prostate cancer.
Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
Daniel A
DA
Barocas
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
JoAnn
J
Alvarez
Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
Matthew J
MJ
Resnick
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
Tatsuki
T
Koyama
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston.
Karen E
KE
Hoffman
Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
Mark D
MD
Tyson
Prostate Cancer Patient Advocate, Vanderbilt Ingram Cancer Center, Nashville, Tennessee.
Ralph
R
Conwill
Prostate Cancer Patient Advocate, Vanderbilt Ingram Cancer Center, Nashville, Tennessee.
Dan
D
McCollum
Department of Urology, University of California, San Francisco Medical Center, San Francisco.
Matthew R
MR
Cooperberg
Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.
Michael
M
Goodman
Center for Health Policy Research and Department of Medicine, University of California, Irvine.
Sheldon
S
Greenfield
Department of Preventative Medicine, Keck School of Medicine, University of Southern California, Los Angeles.
Ann S
AS
Hamilton
Department of Family and Preventative Medicine, University of Utah, Salt Lake City.
Mia
M
Hashibe
Health Policy Research Institute, University of California, Irvine.
Sherrie H
SH
Kaplan
Rutgers Cancer Institute of New Jersey, Rutgers University, New Brunswick.
Lisa E
LE
Paddock
Rutgers Cancer Institute of New Jersey, Rutgers University, New Brunswick.
Antoinette M
AM
Stroup
School of Public Health, Louisiana State University Health Sciences Center, New Orleans.
Xiao-Cheng
XC
Wu
Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee13Tennessee Valley Veterans Administration Health System, Nashville, Tennessee.
David F
DF
Penson
D000368:Aged; D015331:Cohort Studies; D003657:Decision Making; D007172:Erectile Dysfunction / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D007410:Intestinal Diseases / Q000209:etiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy / Q000009:adverse effects* / Q000706:statistics & numerical data; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D011788:Quality of Life; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000209:etiology; D014555:Urination Disorders / Q000209:etiology / Q000503:physiopathology; D057832:Watchful Waiting
D017430:Prostate-Specific Antigen