Longitudinal Evaluation of Intestinal, Haematological and Urinary Toxicity From Pelvic Irradiation for Prostate Cancer

Summary

The prophylactic irradiation of pelvic lymph-nodes by means of Whole-Pelvis Radiotherapy (WPRT) in the treatment of prostate cancer (PCa) is aimed at the timely eradication of microscopic lymph-nodal metastases. Nevertheless, even though delivered by means of modern Intensity-Modulated Radiotherapy (IMRT) techniques, WPRT may result in intestinal, hematologic and urinary toxicity (IT, HT, UT, respectively) severely affecting patients' daily health-related quality-of-life (HRQoL) within the so-called and inadequately investigated Pelvic Radiation Disease.

The aim of this study is to develop sophisticated predictive models of IMRT-WPRT induced patient-reported HT, IT and UT in PCa. The possible correlation between several clinical factors and radiation doses received by various pelvic structures (i.e. pelvic bones subvolumes, intestinal loops, sigmoid, rectum and bladder) and risk and severity of patient-reported IT, UT and HT will be analyzed and robust multi-variable models will be developed and internally validated. A secondary end-point will be the identification of specific symptoms affecting patients' HRQoL during irradiation and in the long term, overall and in different therapeutic settings (radical, adjuvant and salvage). Lastly, possible correlation between HT and UT/IT will be investigated.

Conditions

• Prostate Cancer

Sponsors & Collaborators

• Associazione Italiana per la Ricerca sul Cancro

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• Regina Elena Cancer Institute

  collaborator OTHER

• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

  collaborator OTHER

• Cliniche Humanitas Gavazzeni

  collaborator OTHER

• Centro AKTIS Diagnostica e Terapia

  collaborator UNKNOWN

• Azienda Sanitaria dell'Alto Adige

  collaborator OTHER

• Azienda Sanitaria Locale To4

  collaborator UNKNOWN

• Azienda USL Reggio Emilia - IRCCS

  collaborator OTHER_GOV

• Candiolo Cancer Institute - IRCCS

  collaborator OTHER

• Azienda Sanitaria Locale di Biella

  collaborator OTHER

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

  collaborator OTHER

• Azienda U.S.L. della Valle d'Aosta

  collaborator UNKNOWN

• IRCCS Centro di Riferimento Oncologico della Basilicata

  collaborator OTHER

• IRCCS San Raffaele

  lead OTHER

Principal Investigators

• Cesare Cozzarini, MD · IRCCS San Raffaele Scientific Institute

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2021-12-31

Completion

2026-12-31

Countries

• Italy

Study Locations