Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (P
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ORIGINAL ARTICLE – CLINICAL ONCOLOGY
Results of a randomized trial of treatment modalities in patients with low or early‑intermediate risk prostate cancer (PREFERE trial) Thomas Wiegel1 · Peter Albers2 · Detlef Bartkowiak1 · Roswitha Bussar‑Maatz3 · Martin Härter4 · Glen Kristiansen5 · Peter Martus6 · Stefan Wellek7 · Heinz Schmidberger8 · Klaus Grozinger9 · Peter Renner10 · Fried Schneider11 · Martin Burmester12 · Michael Stöckle13 Received: 19 May 2020 / Accepted: 17 July 2020 © The Author(s) 2020
Abstract Purpose The optimal treatment for patients with low to early-intermediate risk prostate cancer (PCa) remains to be defined. 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 specific 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 confirmed 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. Keywords Prostate cancer · Randomized clinical trial · Prostatectomy · Active surveillance · External beam radiotherapy · Permanent seed implantation
Introduction The incidence of newly detected prostate cancer (PCa) in Germany was 63.710 in 2012 (Robert-Koch-Institute 2016). Three quarters of these cases were cT1 and cT2 tumors. The optimal therapy for low to (early) intermediate risk-profile
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00432-020-03327-2) contains supplementary material, which is available to authorized users. * Thomas Wiegel thomas.wiegel@uniklinik‑ulm.de Extended author information available on the last page of the article
PCa is still under debate (Mottet et al. 2017; Sanda et al. 2018). One randomized clinical trial (RCT), SPCG-4 compared watchful-waiting (WW) with ra
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