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: Arndt-Christian Müller, Daniel Zips, Vanessa Heinrich, Ulf Lamprecht, Otilia Voigt, Susen Burock, Volker Budach, Peter Wust, Pirus Ghadjar
• Journal: Radiation oncology (London, England) (Radiat Oncol) Vol. 10 Pg. 138 (Jul 08 2015) ISSN: 1748-717X [Electronic] England
• PMID: 26152590 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• KLK3 protein, human
• Kallikreins
• Prostate-Specific Antigen

Topics

• Adenocarcinoma (blood, radiotherapy, 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, radiotherapy, therapy)
• Radiotherapy, Intensity-Modulated (methods)
• Salvage Therapy (methods)