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This retrospective study sought to emulate a randomized trial comparing outcomes between prostatectomy and radiation therapy for high-grade (Gleason score 8–10), clinically localized prostate cancer. The data were extracted from the National Cancer Database (2006–2015) and propensity scoring was used to account for between-group baseline differences. In all, 23,990 patients were treated with radical prostatectomy and 2816 with radiation + androgen deprivation therapy. Unadjusted 5-year and 10-year overall survival was 93% and 77% respectively, for surgery; 85% and 55%, respectively for radiation. The marked survival benefit persisted following propensity-scoring adjustment, with HR for surgery of 0.54.
These findings suggest a clinically significant survival benefit for surgery over radiation in this setting.
– Joshua A. Cohn, MD
Abstract
This abstract is available on the publisher's site.
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.
Citation: Urologic Oncology: Seminars & Original Investigations
Radical Prostatectomy Versus External Beam Radiation Therapy for High-Grade, Clinically Localized Prostate Cancer: Emulation of a Target Clinical Trial
Urol. Oncol 2021 Apr 29;[EPub Ahead of Print], C Reitblat, A Fleishman, IA Kaplan, KD Stensland, AV D'Amico, AF Olumi, AA Wagner, PK Chang, SP Kim, R Korets, B Gershman
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.