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Titel: Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial)
VerfasserIn: Wiegel, Thomas
Albers, Peter
Bartkowiak, Detlef
Bussar-Maatz, Roswitha
Härter, Martin
Kristiansen, Glen
Martus, Peter
Wellek, Stefan
Schmidberger, Heinz
Grozinger, Klaus
Renner, Peter
Schneider, Fried
Burmester, Martin
Stöckle, Michael
Sprache: Englisch
Titel: Journal of Cancer Research and Clinical Oncology
Bandnummer: 147 (2021)
Heft: 1
Seiten: 235–242
Verlag/Plattform: Springer Nature
Erscheinungsjahr: 2020
Freie Schlagwörter: Prostate cancer
Randomized clinical trial
Prostatectomy
Active surveillance
External beam radiotherapy
Permanent seed implantation
DDC-Sachgruppe: 610 Medizin, Gesundheit
Dokumenttyp: Journalartikel / Zeitschriftenartikel
Abstract: Purpose The optimal treatment for patients with low to early-intermediate risk prostate cancer (PCa) remains to be defned. The randomized PREFERE trial (DRKS00004405) aimed to assess noninferiority of active surveillance (AS), externalbeam radiotherapy (EBRT), or brachytherapy by permanent seed implantation (PSI) vs. radical prostatectomy (RP) for these patients. Methods PREFERE was planned to enroll 7600 patients. The primary endpoint was disease specifc survival. Patients with PCa stage≤cT2a, cN0/X, M0, PSA ≤10 ng/ml and Gleason-Score≤3+4 at reference pathology were eligible. Patients were allowed to exclude one or two of the four modalities, which yielded eleven combinations for randomization. Sixty-nine German study centers were engaged in PREFERE. Results Of 2251 patients prescreened between 2012 and 2016, 459 agreed to participate in PREFERE. Due to this poor accrual, the trial was stopped. In 345 patients reference pathology confrmed inclusion criteria. Sixty-nine men were assigned to RP, 53 to EBRT, 93 to PSI, and 130 to AS. Forty patients changed treatment shortly after randomization, 21 to AS. Fortyeight AS patients with follow-up received radical treatment. Median follow-up was 19 months. Five patients died, none due to PCa; 8 had biochemical progression after radical therapy. Treatment-related acute grade 3 toxicity was reported in 3 RP patients and 2 PSI patients. Conclusions In this prematurely closed trial, we observed an unexpected high rate of termination of AS and an increased toxicity related to PSI. Patients hesitated to be randomized in a multi-arm trial. The optimal treatment of low and earlyintermediate risk PCa remains unclear.
DOI der Erstveröffentlichung: 10.1007/s00432-020-03327-2
URL der Erstveröffentlichung: https://link.springer.com/article/10.1007/s00432-020-03327-2
Link zu diesem Datensatz: urn:nbn:de:bsz:291--ds-377635
hdl:20.500.11880/34158
http://dx.doi.org/10.22028/D291-37763
ISSN: 1432-1335
0171-5216
Datum des Eintrags: 28-Okt-2022
Bezeichnung des in Beziehung stehenden Objekts: Electronic supplementary material
In Beziehung stehendes Objekt: https://static-content.springer.com/esm/art%3A10.1007%2Fs00432-020-03327-2/MediaObjects/432_2020_3327_MOESM1_ESM.pdf
Fakultät: M - Medizinische Fakultät
Fachrichtung: M - Urologie und Kinderurologie
Professur: M - Prof. Dr. Michael Stöckle
Sammlung:SciDok - Der Wissenschaftsserver der Universität des Saarlandes

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