Please use this identifier to cite or link to this item: doi:10.22028/D291-37763
Title: Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial)
Author(s): 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
Language: English
Title: Journal of Cancer Research and Clinical Oncology
Volume: 147 (2021)
Issue: 1
Pages: 235–242
Publisher/Platform: Springer Nature
Year of Publication: 2020
Free key words: Prostate cancer
Randomized clinical trial
Active surveillance
External beam radiotherapy
Permanent seed implantation
DDC notations: 610 Medicine and health
Publikation type: Journal Article
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 of the first publication: 10.1007/s00432-020-03327-2
URL of the first publication:
Link to this record: urn:nbn:de:bsz:291--ds-377635
ISSN: 1432-1335
Date of registration: 28-Oct-2022
Description of the related object: Electronic supplementary material
Related object:
Faculty: M - Medizinische Fakultät
Department: M - Urologie und Kinderurologie
Professorship: M - Prof. Dr. Michael Stöckle
Collections:SciDok - Der Wissenschaftsserver der Universität des Saarlandes

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