title: Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. arndt-christian.mueller@med.uni-tuebingen.de.
authors.forename: Arndt-Christian
authors.initials: AC
authors.lastname: Müller
authors.affiliation: Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. daniel.zips@med.uni-tuebingen.de.
authors.forename: Daniel
authors.initials: D
authors.lastname: Zips
authors.affiliation: Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. vanessa.heinrich@med.uni-tuebingen.de.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Heinrich
authors.affiliation: Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. ulf.lamprecht@med.uni-tuebingen.de.
authors.forename: Ulf
authors.initials: U
authors.lastname: Lamprecht
authors.affiliation: Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. otilia.voigt@med.uni-tuebingen.de.
authors.forename: Otilia
authors.initials: O
authors.lastname: Voigt
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. susen.burock@charite.de.
authors.forename: Susen
authors.initials: S
authors.lastname: Burock
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. volker.budach@charite.de.
authors.forename: Volker
authors.initials: V
authors.lastname: Budach
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. peter.wust@charite.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Wust
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. pirus.ghadjar@charite.de.
authors.forename: Pirus
authors.initials: P
authors.lastname: Ghadjar
mesh_terms: D006801:Humans; D008297:Male; D008875:Middle Aged; D000230:Adenocarcinoma / Q000097:blood / Q000532:radiotherapy / Q000628:therapy; D017322:Clinical Trials, Phase II as Topic; D003131:Combined Modality Therapy; D023381:Endpoint Determination; D005060:Europe; D005240:Feasibility Studies; D006979:Hyperthermia, Induced; D007610:Kallikreins / Q000097:blood; D009364:Neoplasm Recurrence, Local / Q000532:radiotherapy; D018579:Patient Selection; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000532:radiotherapy / Q000628:therapy; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods; D016879:Salvage Therapy / Q000379:methods; D015337:Multicenter Studies as Topic
chemical_list: D007610:Kallikreins; C549870:KLK3 protein, human; D017430:Prostate-Specific Antigen