Estimating the Effect of Radical Prostatectomy: Combining Data From the SPCG4 and PIVOT Randomized Trials With Contemporary Cohorts

No AccessJournal of UrologyOriginal Clinical Article12 Jun 2024Estimating the Effect of Radical Prostatectomy: Combining Data From the SPCG4 and PIVOT Randomized Trials With Contemporary CohortsThis article is commented on by the following:Editorial CommentEditorial Comment Andrew Vickers, Emily Vertosick, Lisa Langsetmo, Philipp Dahm, Gunnar Steineck, and Timothy J. Wilt Andrew VickersAndrew Vickers Corresponding Author: Andrew J. Vickers, PhD, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York, NY 10017 ([email protected]) , Emily VertosickEmily Vertosick Memorial Sloan Kettering Cancer Center , Lisa LangsetmoLisa Langsetmo Minneapolis Veterans Affairs Medical Center University of Minnesota School of Medicine , Philipp DahmPhilipp Dahm Minneapolis Veterans Affairs Medical Center University of Minnesota School of Medicine , Gunnar SteineckGunnar Steineck University of Gothenburg , and Timothy J. WiltTimothy J. Wilt Minneapolis Veterans Affairs Medical Center University of Minnesota School of Medicine University of Minnesota School of Public Health View All Author Informationhttps://doi.org/10.1097/JU.0000000000004039AboutFull TextPDF Cite Export CitationSelect Citation formatNLMIEEEACMAPAChicagoMLAHarvardTips on citation downloadDownload citationCopy citation ToolsAdd to favoritesTrack Citations ShareFacebookLinked InTwitterEmail Abstract Purpose: Two randomized trials (SPCG4 and PIVOT) have compared surgery to conservative management for localized prostate cancer. The applicability of these trials to contemporary practice remains uncertain. We aimed to develop an individualized prediction model for prostate cancer mortality comparing immediate surgery at a high-volume center to active surveillance. Materials and Methods: We determined whether the relative risk of prostate cancer mortality with surgery vs observation varied by baseline risk. We then used various estimates of relative risk to estimate 15-year mortality with and without surgery using, as a predictor, risk of biochemical recurrence calculated from a model. Results: We saw no evidence that relative risk varied by baseline risk, supporting the use of a constant relative risk. Compared with observation, surgery was associated with negligible benefit for patients with Grade Group (GG) 1 disease (0.2% mortality reduction at 15 years) and small benefit for patients with GG2 with lower PSA and stage (≤5% mortality reduction). Benefit was greater (6%-9%) for patients with GG3 or GG4 though still modest, but effect estimates varied widely depending on choice of hazard ratio for surgery (6%-36% absolute risk reduction). Conclusions: Surgery should be avoided for men with low-risk (GG1) prostate cancer and for many men with GG2 disease. Surgical benefits are greater in men with higher-risk disease. 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Conflict of Interest Disclosures: Dr Vickers is a co-inventor of the 4kscore, a commercial test for predicting prostate biopsy outcome and receives royalties from sales of the test; he also owns stock options in Opko, which offers the test. Dr Wilt reported receiving a VA-CSP grant to conduct the PIVOT, which he served as principal investigator of and which is discussed in this paper. No other disclosures were reported. Ethics Statement: In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. Author Contributions: Conception and design: Vickers. Acquisition of data: Vickers, Steineck, Dahm, TW, Langsetmo. Analysis and interpretation of data: Vickers, Steineck, Dahm, Wilt, Langsetmo. Drafting of the manuscript: Vickers. Critical revision of manuscript: Vickers, Vertosick, Steineck, Wilt, Langsetmo. Statistical analysis: Vertosick. Obtaining funding: Vickers. Data Availability: This is a secondary analysis of 2 well-known randomized trials. Researchers interested in the data should contact the original trialists. © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byGlaser A Editorial CommentJournal of Urology, Basourakos S and Shoag J Editorial CommentJournal of Urology, Related articlesJournal of Urology12 Jun 2024Editorial CommentJournal of Urology12 Jun 2024Editorial Comment Supplementary Materials Peer Review Report Open Peer Review Report Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.KeywordsprostatectomyMetrics Author Information Andrew Vickers Corresponding Author: Andrew J. Vickers, PhD, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York, NY 10017 ([email protected]) More articles by this author Emily Vertosick Memorial Sloan Kettering Cancer Center More articles by this author Lisa Langsetmo Minneapolis Veterans Affairs Medical Center University of Minnesota School of Medicine More articles by this author Philipp Dahm Minneapolis Veterans Affairs Medical Center University of Minnesota School of Medicine More articles by this author Gunnar Steineck University of Gothenburg More articles by this author Timothy J. Wilt Minneapolis Veterans Affairs Medical Center University of Minnesota School of Medicine University of Minnesota School of Public Health More articles by this author Expand All Recusal: Dr Mulhall, editorial board member of The Journal of Urology®, was recused from the editorial and peer review processes due to affiliation with Memorial Sloan Kettering Cancer Center. Funding/Support: This work was supported in part by the National Institutes of Health/National Cancer Institute (NIH/NCI) with a Cancer Center Support Grant to Memorial Sloan Kettering Cancer Center (P30 CA008748). Conflict of Interest Disclosures: Dr Vickers is a co-inventor of the 4kscore, a commercial test for predicting prostate biopsy outcome and receives royalties from sales of the test; he also owns stock options in Opko, which offers the test. Dr Wilt reported receiving a VA-CSP grant to conduct the PIVOT, which he served as principal investigator of and which is discussed in this paper. No other disclosures were reported. Ethics Statement: In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. Author Contributions: Conception and design: Vickers. Acquisition of data: Vickers, Steineck, Dahm, TW, Langsetmo. Analysis and interpretation of data: Vickers, Steineck, Dahm, Wilt, Langsetmo. Drafting of the manuscript: Vickers. Critical revision of manuscript: Vickers, Vertosick, Steineck, Wilt, Langsetmo. Statistical analysis: Vertosick. Obtaining funding: Vickers. Data Availability: This is a secondary analysis of 2 well-known randomized trials. Researchers interested in the data should contact the original trialists. Advertisement PDF downloadLoading ...