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Original Investigation
January 14, 2020

Patient-Reported Outcomes Through 5 Years for Active Surveillance, Surgery, Brachytherapy, or External Beam Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer

Author Affiliations
  • 1Department of Radiation Oncology, The University of Texas MD Anderson Center, Houston
  • 2Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee
  • 3Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee
  • 4Office of Patient and Community Education, Patient Advocacy Program, Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee
  • 5Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia
  • 6Department of Preventative Medicine, Keck School of Medicine at the University of Southern California, Los Angeles
  • 7Department of Epidemiology, Louisiana State University New Orleans School of Public Health, New Orleans
  • 8Department of Epidemiology, Cancer Institute of New Jersey, Rutgers Health, New Brunswick
  • 9Department of Urology, University of California, San Francisco
  • 10Department of Family and Preventative Medicine, University of Utah School of Medicine, Salt Lake City
  • 11Department of Urology, University of Utah Health, Salt Lake City
  • 12Department of Medicine, University of California Irvine, Irvine
JAMA. 2020;323(2):149-163. doi:10.1001/jama.2019.20675
Key Points

Question  What are the comparative harms of contemporary treatments for localized prostate cancer through 5 years?

Findings  In this prospective, population-based study of 1386 men with favorable-risk prostate cancer and 619 men with unfavorable-risk prostate cancer, most functional differences, measured with Expanded Prostate Cancer Index Composite scores, associated with treatments (favorable-risk disease: active surveillance, nerve-sparing prostatectomy, external beam radiation therapy, or low-dose-rate brachytherapy; unfavorable-risk disease: prostatectomy or external beam radiation therapy with androgen deprivation therapy) attenuated over time with no clinically meaningful bowel or hormonal functional differences at 5 years. However, prostatectomy was associated with worse incontinence over 5 years (adjusted mean difference of –10.9 for favorable-risk disease and −23.2 for unfavorable-risk disease) and worse sexual function at 5 years for unfavorable-risk disease (adjusted mean difference, −12.5).

Meaning  These estimates of the long-term bowel, bladder and sexual function after localized prostate cancer treatment may clarify expectations and enable men to make informed choices about care.

Abstract

Importance  Understanding adverse effects of contemporary treatment approaches for men with favorable-risk and unfavorable-risk localized prostate cancer could inform treatment selection.

Objective  To compare functional outcomes associated with prostate cancer treatments over 5 years after treatment.

Design, Setting, and Participants  Prospective, population-based cohort study of 1386 men with favorable-risk (clinical stage cT1 to cT2bN0M0, prostate-specific antigen [PSA] ≤20 ng/mL, and Grade Group 1-2) prostate cancer and 619 men with unfavorable-risk (clinical stage cT2cN0M0, PSA of 20-50 ng/mL, or Grade Group 3-5) prostate cancer diagnosed in 2011 through 2012, accrued from 5 Surveillance, Epidemiology and End Results Program sites and a US prostate cancer registry, with surveys through September 2017.

Exposures  Treatment with active surveillance (n = 363), nerve-sparing prostatectomy (n = 675), external beam radiation therapy (EBRT; n = 261), or low-dose-rate brachytherapy (n = 87) for men with favorable-risk disease and treatment with prostatectomy (n = 402) or EBRT with androgen deprivation therapy (n = 217) for men with unfavorable-risk disease.

Main Outcomes and Measures  Patient-reported function, based on the 26-item Expanded Prostate Index Composite (range, 0-100), 5 years after treatment. Regression models were adjusted for baseline function and patient and tumor characteristics. Minimum clinically important difference was 10 to 12 for sexual function, 6 to 9 for urinary incontinence, 5 to 7 for urinary irritative symptoms, and 4 to 6 for bowel and hormonal function.

Results  A total of 2005 men met inclusion criteria and completed the baseline and at least 1 postbaseline survey (median [interquartile range] age, 64 [59-70] years; 1529 of 1993 participants [77%] were non-Hispanic white). For men with favorable-risk prostate cancer, nerve-sparing prostatectomy was associated with worse urinary incontinence at 5 years (adjusted mean difference, −10.9 [95% CI, −14.2 to −7.6]) and sexual function at 3 years (adjusted mean difference, −15.2 [95% CI, −18.8 to −11.5]) compared with active surveillance. Low-dose-rate brachytherapy was associated with worse urinary irritative (adjusted mean difference, −7.0 [95% CI, −10.1 to −3.9]), sexual (adjusted mean difference, −10.1 [95% CI, −14.6 to −5.7]), and bowel (adjusted mean difference, −5.0 [95% CI, −7.6 to −2.4]) function at 1 year compared with active surveillance. EBRT was associated with urinary, sexual, and bowel function changes not clinically different from active surveillance at any time point through 5 years. For men with unfavorable-risk disease, EBRT with ADT was associated with lower hormonal function at 6 months (adjusted mean difference, −5.3 [95% CI, −8.2 to −2.4]) and bowel function at 1 year (adjusted mean difference, −4.1 [95% CI, −6.3 to −1.9]), but better sexual function at 5 years (adjusted mean difference, 12.5 [95% CI, 6.2-18.7]) and incontinence at each time point through 5 years (adjusted mean difference, 23.2 [95% CI, 17.7-28.7]), than prostatectomy.

Conclusions and Relevance  In this cohort of men with localized prostate cancer, most functional differences associated with contemporary management options attenuated by 5 years. However, men undergoing prostatectomy reported clinically meaningful worse incontinence through 5 years compared with all other options, and men undergoing prostatectomy for unfavorable-risk disease reported worse sexual function at 5 years compared with men who underwent EBRT with ADT.

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