Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension

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dc.contributor University of Helsinki, HUS Abdominal Center en
dc.contributor University of Helsinki, HUS Abdominal Center en
dc.contributor University of Helsinki, HUS Comprehensive Cancer Center en
dc.contributor University of Helsinki, HUS Comprehensive Cancer Center en
dc.contributor University of Helsinki, HYKS erva en
dc.contributor University of Helsinki, HUS Abdominal Center en
dc.contributor University of Helsinki, Päijät-Häme Welfare Consortium en
dc.contributor University of Helsinki, Department of Oncology en
dc.contributor.author FinnProstate Grp
dc.contributor.author Hackman, Greetta
dc.contributor.author Taari, Kimmo
dc.contributor.author Tammela, Teuvo L.
dc.contributor.author Matikainen, Mika
dc.contributor.author Kouri, Mauri
dc.contributor.author Joensuu, Timo
dc.contributor.author Luukkaala, Tiina
dc.contributor.author Salonen, Arto
dc.contributor.author Isotalo, Taina
dc.contributor.author Petas, Anssi
dc.contributor.author Hendolin, Niilo
dc.contributor.author Boström, Peter J.
dc.contributor.author Aaltomaa, Sirpa
dc.contributor.author Lehtoranta, Kari
dc.contributor.author Hellström, Pekka
dc.contributor.author Riikonen, Jarno
dc.contributor.author Korpela, Merja
dc.contributor.author Minn, Heikki
dc.contributor.author Kellokumpu-Lehtinen, Pirkko-Liisa
dc.contributor.author Pukkala, Eero
dc.contributor.author Hemminki, Akseli
dc.date.accessioned 2019-11-08T08:54:02Z
dc.date.available 2020-08-13T21:01:10Z
dc.date.issued 2019-11
dc.identifier.citation FinnProstate Grp , Hackman , G , Taari , K , Tammela , T L , Matikainen , M , Kouri , M , Joensuu , T , Luukkaala , T , Salonen , A , Isotalo , T , Petas , A , Hendolin , N , Boström , P J , Aaltomaa , S , Lehtoranta , K , Hellström , P , Riikonen , J , Korpela , M , Minn , H , Kellokumpu-Lehtinen , P-L , Pukkala , E & Hemminki , A 2019 , ' Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension ' , European Urology , vol. 76 , no. 5 , pp. 586-595 . https://doi.org/10.1016/j.eururo.2019.07.001 en
dc.identifier.issn 0302-2838
dc.identifier.other PURE: 127988207
dc.identifier.other PURE UUID: bb843c57-cd38-4337-8302-fecdbcb11628
dc.identifier.other WOS: 000490122200024
dc.identifier.other ORCID: /0000-0002-0077-4896/work/64326057
dc.identifier.uri http://hdl.handle.net/10138/306830
dc.description.abstract Background: It remains unclear whether patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy. Objective: To compare the effectiveness and tolerability of adjuvant radiotherapy following radical prostatectomy. Design, setting, and participants: This was a randomised, open-label, parallel-group trial. A total of 250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion. Intervention: A total of 126 patients received adjuvant radiotherapy at 66.6 Gy. Outcome measurements and statistical analysis: The primary endpoint was biochemical recurrence-free survival, which we analysed using the Kaplan-Meier method and Cox proportional hazard regression. Overall survival, cancer-specific survival, local recurrence, and adverse events were secondary endpoints. Results and limitations: The median follow-up time for patients who were alive when the follow-up ended was 9.3 yr in the adjuvant group and 8.6 yr in the observation group. The 10-yr survival for biochemical recurrence was 82% in the adjuvant group and 61% in the observation group (hazard ratio [HR] 0.26 [95% confidence interval {CI} 0.14-0.48], p <0.001), and for overall survival 92% and 87%, respectively (HR 0.69 [95% CI 0.29-1.60], p = 0.4). Two and four metastatic cancers occurred, respectively. Out of the 43 patients with biochemical recurrence in the observation group, 37 patients received salvage radiotherapy. In the adjuvant group, 56% experienced grade 3 adverse events, versus 40% in the observation group (p = 0.016). Only one grade 4 adverse event occurred (adjuvant group). A limitation of this study was the number of patients. Conclusions: Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension. Patient summary: Radiotherapy given immediately after prostate cancer surgery prolongs prostate-specific antigen progression-free survival, but causes more adverse events, when compared with surgery alone. (C) 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved. en
dc.format.extent 10
dc.language.iso eng
dc.relation.ispartof European Urology
dc.rights en
dc.subject Adjuvant radiotherapy en
dc.subject Extracapsular extension en
dc.subject Prostate cancer en
dc.subject Positive margins en
dc.subject Radical prostatectomy en
dc.subject SALVAGE RADIATION-THERAPY en
dc.subject SEMINAL-VESICLE INVASION en
dc.subject BIOCHEMICAL RECURRENCE en
dc.subject OUTCOMES en
dc.subject ADENOCARCINOMA en
dc.subject SURVIVAL en
dc.subject PREDICT en
dc.subject RATES en
dc.subject RISK en
dc.subject PT3B en
dc.subject 3126 Surgery, anesthesiology, intensive care, radiology en
dc.subject 3122 Cancers en
dc.title Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension en
dc.type Article
dc.description.version Peer reviewed
dc.description.version Non Peer reviewed
dc.identifier.doi https://doi.org/10.1016/j.eururo.2019.07.001
dc.type.uri info:eu-repo/semantics/other
dc.type.uri info:eu-repo/semantics/publishedVersion
dc.type.uri http://purl.org/eprint/status/NonPeerReviewed
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