Abstract | PURPOSE: The comparative effectiveness of surgery and radiation therapy for high-grade, clinically localized prostate cancer remains a seminal, open question in urologic oncology, with no randomized controlled trials to inform management. We therefore emulated a hypothetical target clinical trial of radical prostatectomy (RP) versus external beam radiotherapy (EBRT) for high-grade, clinically localized prostate cancer. MATERIALS AND METHODS: We conducted observational analyses using the National Cancer Database from 2006-2015 to emulate a target clinical trial in men 55-69 years with cT1-3cN0cM0, PSA<20 ng/mL, Gleason 8 to 10 prostate adenocarcinoma treated with RP or 75 to 81 Gy EBRT with androgen deprivation therapy (EBRT+ADT). The associations of treatment type with overall survival (OS) were estimated using Cox regression with stabilized inverse probability weights (IPW). RESULTS: A total of 26,806 men formed the study cohort (RP: 23,990; EBRT+ADT: 2,816). Baseline characteristics were well-balanced after IPW-adjustment. Median follow-up was 48.4 (IQR 25.5-76.2) months. After IPW-reweighting, RP was associated with improved OS compared to EBRT+ADT (HR 0.54;95% CI 0.48-0.62; P<0.001), with 5- and 10-year OS of 93% vs 87%, and 76% vs 60%, respectively. RP was associated with improved OS across all categories of Gleason score, PSA, cT stage, age, and Charlson comorbidity index examined. In sensitivity analyses adjusting for biopsy tumor volume and a biopsy-specific Gleason score, RP remained associated with improved OS compared to EBRT+ADT (HR 0.62;95% CI 0.49-0.78; P<0.001). CONCLUSIONS: In observational analyses designed to emulate a target clinical trial of men with high-grade, clinically localized prostate cancer, RP was associated with improved OS compared with EBRT+ADT.
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Authors | Chanan Reitblat, Aaron Fleishman, Irving A Kaplan, Kristian D Stensland, Anthony V D'Amico, Aria F Olumi, Andrew A Wagner, Peter K Chang, Simon P Kim, Ruslan Korets, Boris Gershman |
Journal | Urologic oncology
(Urol Oncol)
Vol. 39
Issue 11
Pg. 785.e1-785.e10
(11 2021)
ISSN: 1873-2496 [Electronic] United States |
PMID | 33934965
(Publication Type: Journal Article)
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Copyright | Copyright © 2021 Elsevier Inc. All rights reserved. |
Topics |
- Aged
- Brachytherapy
(methods)
- Clinical Trials as Topic
- Humans
- Male
- Middle Aged
- Neoplasm Grading
- Prostatectomy
(methods)
- Prostatic Neoplasms
(pathology, radiotherapy, surgery)
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