Benefits of Elective Para-Aortic Radiotherapy for pN1 Prostate Cancer Using Arc Therapy (Intensity-Modulated or Volumetric Modulated Arc Therapy): Protocol for a Nonrandomized Phase II Trial

Cédric Draulans; Steven Joniau; Valérie Fonteyne; Louke Delrue; Karel Decaestecker; Wouter Everaerts; Piet Dirix; Laura Van den Bergh; Wouter Crijns; Hans Vandendriessche; Lodewijk Van Wynsberge; Piet Ost; Nicolaas Lumen; Pieterjan Buelens; Karin Haustermans; Charlien Berghen; Gert De Meerleer

doi:10.2196/11256

Benefits of Elective Para-Aortic Radiotherapy for pN1 Prostate Cancer Using Arc Therapy (Intensity-Modulated or Volumetric Modulated Arc Therapy): Protocol for a Nonrandomized Phase II Trial

JMIR Res Protoc. 2018 Dec 13;7(12):e11256. doi: 10.2196/11256.

Authors

Cédric Draulans¹, Steven Joniau², Valérie Fonteyne³, Louke Delrue⁴, Karel Decaestecker⁵, Wouter Everaerts², Piet Dirix⁶, Laura Van den Bergh⁷, Wouter Crijns¹, Hans Vandendriessche⁸, Lodewijk Van Wynsberge⁹, Piet Ost³, Nicolaas Lumen⁵, Pieterjan Buelens¹, Karin Haustermans¹, Charlien Berghen¹, Gert De Meerleer¹

Affiliations

¹ Department of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.
² Department of Urology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.
³ Department of Radiation Oncology, Ghent University Hospital, University of Ghent, Ghent, Belgium.
⁴ Department of Radiology, Ghent University Hospital, University of Ghent, Ghent, Belgium.
⁵ Department of Urology, Ghent University Hospital, University of Ghent, Ghent, Belgium.
⁶ Department of Radiation Oncology, Iridium Cancer Network, Wilrijk, Antwerp, Belgium.
⁷ Department of Radiation Oncology, Limburg Oncology Centre, Hasselt, Belgium.
⁸ Department of Urology, AZ Jan Portaels, Vilvoorde, Belgium.
⁹ Department of Urology, General Regional Hospital Tienen, Tienen, Belgium.

PMID: 30545809
PMCID: PMC6315267
DOI: 10.2196/11256

Abstract

Background: In patients with prostate cancer (PCa) with histopathologically proven pelvic lymph node (LN) metastasis (pN1) after extended pelvic lymph node dissection (ePLND), multimodality treatment consisting of treatment of the primary tumor and whole pelvic radiotherapy (WPRT) combined with androgen deprivation therapy (ADT) offers promising results, leading to better cause-specific survival rates compared with ADT alone. However, in case more than one pelvic LN is invaded by the tumor, approximately 40% of the patients relapse biochemically and clinically. Clinical relapse is present in the para-aortic LNs (M1a disease) in up to 77% of the relapsing cases.

Objective: We hypothesize that, based on the evidence that positive LNs represent the door to hematogenous dissemination, elective para-aortic irradiation will reduce the development of both retroperitoneal nodal (M1a) and distant metastasis (M1b or M1c disease), postpone the need for palliative ADT, and prolong the time to castration-refractory disease.

Methods: To test this hypothesis, we will conduct a prospective, nonrandomized phase II trial to study the efficacy of additional elective para-aortic radiotherapy (PART) in pN1 patients compared with those who were historically treated with adjuvant WPRT alone. We aim to include 137 patients with PCa and presence of pN1 disease after ePLND. With this number of patients, an improvement of 15% in the 5-year clinical relapse-free survival can be detected with a power of 80%.

Results: Recruitment of patients for this trial started in 2017 and will be completed approximately by March 2020.

Conclusions: This is the first phase II trial to investigate the benefits of an elective PART in patients with PCa. The results of this trial will potentially serve as a sound base for a later randomized phase III trial. All participants are given a PART information sheet and required to give written informed consent. Results are expected to be published in a peer-reviewed journal.

Trial registration: ClinicalTrials.gov NCT03079323; https://clinicaltrials.gov/ct2/show/NCT03079323 (Archived by WebCite at http://www.webcitation.org/73ELimv1d).

International registered report identifier (irrid): PRR1-10.2196/11256.

Keywords: PART trial; elective para-aortic radiotherapy; external beam radiotherapy; prostate cancer.

©Cédric Draulans, Steven Joniau, Valérie Fonteyne, Louke Delrue, Karel Decaestecker, Wouter Everaerts, Piet Dirix, Laura Van den Bergh, Wouter Crijns, Hans Vandendriessche, Lodewijk Van Wynsberge, Piet Ost, Nicolaas Lumen, Pieterjan Buelens, Karin Haustermans, Charlien Berghen, Gert De Meerleer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.12.2018.

Associated data

ClinicalTrials.gov/NCT03079323