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

• DOI: 10.2196/11256
• Publication Date: 2018-08-02T09:57:57Z
• Authors: Cédric Draulans; Steven Joniau; Valérie Fonteyne; Louke Delrue; Karel Decaestecker; Wouter Everaerts; Piet Dirix; Laura Van den Bergh; Wouter Crijns; Hans Vandendriessche; Lodewijk Van Wyns...; Piet Ost; Nicolaas Lumen; Pieterjan Buelens; Karin Haustermans; Charlien Berghen; Gert De Meerleer
• Keywords: PROSTATECTOMY; elective para-aortic radiotherapy; PART; trial; prostate cancer; external beam radiotherapy; RADICAL; 6. Clean water; 3. Good health; LYMPH-NODE DISSECTION; TARGET VOLUME; 03 medical and health sciences; METASTASES; 0302 clinical medicine; QUALITY-OF-LIFE; RADIATION-THERAPY; Medicine and Health Sciences; ANDROGEN DEPRIVATION; Protocol; ESTRO-SIOG GUIDELINES; FREE SURVIVAL; FOLLOW-UP

In patients with prostate cancer (PCa) histopathologically proven pelvic lymph node (LN) metastasis (pN1) after extended dissection (ePLND), multimodality treatment consisting of the primary tumor and whole radiotherapy (WPRT) combined androgen deprivation therapy (ADT) offers promising results, leading to better cause-specific survival rates compared ADT alone. However, in case more than one LN is invaded by tumor, approximately 40% relapse biochemically clinically. Clinical present para-aortic LNs (M1a disease) up 77% relapsing cases.We hypothesize that, based on evidence that positive represent door hematogenous dissemination, elective irradiation will reduce development both retroperitoneal nodal (M1a) distant (M1b or M1c disease), postpone need for palliative ADT, prolong time castration-refractory disease.To test this hypothesis, we conduct a prospective, nonrandomized phase II trial study efficacy additional (PART) pN1 those who were historically treated adjuvant WPRT We aim include 137 PCa presence disease ePLND. With number patients, an improvement 15% 5-year clinical relapse-free can be detected power 80%.Recruitment started 2017 completed March 2020.This first investigate benefits PART PCa. The results potentially serve as sound base later randomized III trial. All participants are given information sheet required give written informed consent. Results expected published peer-reviewed journal.ClinicalTrials.gov NCT03079323; https://clinicaltrials.gov/ct2/show/NCT03079323 (Archived WebCite at http://www.webcitation.org/73ELimv1d).PRR1-10.2196/11256.