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

Radiat Oncol. 2015 Jul 8;10:138. doi: 10.1186/s13014-015-0442-4.

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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adenocarcinoma / blood
  • Adenocarcinoma / radiotherapy*
  • Adenocarcinoma / therapy
  • Combined Modality Therapy
  • Endpoint Determination
  • Europe
  • Feasibility Studies
  • Humans
  • Hyperthermia, Induced*
  • Kallikreins / blood
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / radiotherapy*
  • Patient Selection
  • Prostate-Specific Antigen / blood
  • Prostatectomy
  • Prostatic Neoplasms / blood
  • Prostatic Neoplasms / radiotherapy*
  • Prostatic Neoplasms / therapy
  • Radiotherapy, Intensity-Modulated / methods
  • Salvage Therapy / methods*

Substances

  • Kallikreins
  • kallikrein-related peptidase 3, human
  • Prostate-Specific Antigen