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July11, 2024
MutlaySayan,MD4; DeryaTilki,MD1,2; Anthony V.D’Amico,MD, PhD3
Author Affiliations Article Information
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1Department of Urology and Martini-Klinik Prostate Cancer Center, University Hospital Hamburg Eppendorf, Hamburg, Germany
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2Department of Urology, Koc University Hospital, Istanbul, Turkey
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3Department of Radiation Oncology, Brigham and Women’s Hospital and Dana Farber Cancer Institute, Boston, Massachusetts
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4Department of Radiation Oncology, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, Massachusetts
JAMA Oncol. Published online July 11, 2024. doi:10.1001/jamaoncol.2024.1887
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The current standard-of-care follow-up protocol for patients who have undergone a radical prostatectomy—irrespective of prostatectomy (p) stage, margin status, or Gleason score—is monitoring with an ultrasensitive prostate-specific antigen (PSA) test and the initiation of salvage radiation therapy (RT) if the PSA level reaches or exceeds 0.1 ng/mL (to convert PSA to µg/L, multiply by 1). This practice is supported by a meta-analysis of 3 prospective randomized clinical trials (RCTs),1 which derived its conclusion from examination of the end point of progression-free survival (PFS), primarily influenced by PSA failure. However, it is important to note that the primary end point of the RADICALS-RT trial,2 the largest of the 3 RCTs included in this meta-analysis, was freedom from distant metastases (FFDM). However, as the other 2 RCTs approached the reporting of their primary end point, being PFS, a decision was made to consolidate the data and evaluate PFS, even though it was a secondary end point in the RADICALS-RT study.2
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July 13, 2024
Randomized Clinical Trial vs Expert Opinion
Takeshi Takehashi, M.D, Ph.D | Health and welfare bureau
In the RADICALS-RT trial discussed in this article, all aspects of medical practice under investigation are empirical. Despite its classification as a randomized controlled trial (RCT), its scientific and clinical validity, both internally and externally, is limited. Clinical practices related to prostate cancer screening, including Gleason score, surgery, radiation, and definitions of biochemical recurrence, predominantly rely on expert consensus and case series rather than robust scientific evidence. The malignant potential of screen-detected cancers remains scientifically unvalidated. Dr. Chadok's review of prostate cancer screening in the 1980s, before the introduction of PSA testing, cautioned, "Prostate cancer screening should be considered In 2018, the USPSTF reviewed several RCTs (PLCO, ERSPC, CAP), finding no reduction in all-cause mortality and inconsistent effects on cancer-specific mortality [3]. These trial results do not sufficiently address Dr. Chadok's concerns [1]. The SPCG4 RCT favored surgery over surveillance for clinical cancer treatment, while the ProtecT trial showed no advantage for surgery or radiation therapy over surveillance, indicating similar outcomes without treatment [3,4]. Significant divergence exists between perspectives of public health physicians (USPSTF) and urologists, leaving healthcare professionals uncertain about the optimal approach. The USPSTF categorizes PSA screening within an early phase clinical trial or experimental context, reflecting its Grade C designation. Subsequently, urologists have developed successive guidelines through national societies and other organizations, all advocating for PSA screening [2,5]. In the evidence hierarchy, randomized controlled trials (RCTs) stand as the gold standard, followed by prospective cohort and case-control studies. In contrast, case reports and expert opinions carry less weight. While public health physicians specialize in evidence evaluation, their focus extends beyond prostate cancer. Thus, while the USPSTF statement is grounded in evidence, guidelines from urology societies represent expert consensus. REFERENCE 1. Chodak GW, World J Surg. 1989 Jan-Feb;13(1):60-4.
2. Catalona WJ. Med Clin North Am. 2018 Mar;102(2):199-214. doi: 10.1016/j.mcna.2017.11.001.
3. Fenton JJ, Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 May. Report No.: 17-05229-EF-1.
4. Takahashi T. Virchows Arch. 2024 Apr 11. doi: 10.1007/s00428-024-03804-w.
5. Van Poppel H, Eur Urol. 2021 Dec;80(6):703-711. doi: 10.1016/j.eururo.2021.07.024.
CONFLICT OF INTEREST: None Reported
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Oncology Surgical Oncology Reproductive Health Prostate Cancer Urology Urologic Cancer Surgery Perioperative Care and Consultation
Citation
Sayan M, Tilki D, D’Amico AV. Postoperative Management of Prostate Cancer—Optimizing Prostate Cancer Care. JAMA Oncol. Published online July 11, 2024. doi:10.1001/jamaoncol.2024.1887
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