Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial.

Current studies on salvage radiotherapy (sRT) investigate timing, dose-escalation and anti-hormonal treatment (ADT) for recurrent prostate cancer. These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of long-term ADT.

A phase II protocol was developed to investigate the benefit and tolerability of regional hyperthermia with moderately dose-escalated radiotherapy.

The study hypothesis is that radio-thermotherapy is a safe and feasible salvage treatment modality. The primary endpoint is safety measured by frequency of grade 3+ genitourinary (GU) and gastrointestinal (GI) adverse events (AE) according to Common Toxicity Criteria (CTC) version 4. Feasibility is defined by number of hyperthermia treatments (n ≥ 7) and feasibility of radiotherapy according to protocol. Target volume delineation is performed according to the EORTC guidelines. Radiation treatment is administered with single doses of 2 Gy 5×/week to a total dose of 70 Gy. Regional hyperthermia is given 2×/week to a total of 10 treatments.

European centres participate in the phase II trial using intensity modulated RT (IMRT) or volumetric modulated arc technique (VMAT). The initiating centres were participants of the SAKK 09/10 study, where the same patient criteria and target volume definition (mandatory successful performed dummy run) were applied insuring a high standardisation of the study procedures.

The introduced phase II study implements highly precise image-guided radiotherapy and regional hyperthermia. If the phase II study is found to be safe and feasible, a multicenter phase III study is planned to test whether the addition of regional hyperthermia to dose-intensified sRT improves biochemical control.

Radiation oncology (London, England) 2015 Jul 08*** epublish ***

Arndt-Christian Müller, Daniel Zips, Vanessa Heinrich, Ulf Lamprecht, Otilia Voigt, Susen Burock, Volker Budach, Peter Wust, Pirus Ghadjar

Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str 3, 72076, Tübingen, Germany arndt-christian mueller@med uni-tuebingen de , Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str 3, 72076, Tübingen, Germany daniel zips@med uni-tuebingen de , Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str 3, 72076, Tübingen, Germany vanessa heinrich@med uni-tuebingen de , Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str 3, 72076, Tübingen, Germany ulf lamprecht@med uni-tuebingen de , Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str 3, 72076, Tübingen, Germany otilia voigt@med uni-tuebingen de , Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany susen burock@charite de , Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany volker budach@charite de , Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany peter wust@charite de , Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

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