NCT03340272

PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.

PROspective Multicenter Observational Study on Elective Pelvic Nodes (PRO-EPI) Irradiation in Patients With Intermediate/High/Very High Risk Prostate Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT). The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.

Detailed description

Clinical features and outcomes of the patients included in the study will be assessed as better detailed in the following lines: 1. To define the diffusion of the practice of treating pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer (PCa) among Italian Radiation Oncology Centers, submitted to radical or post-operative radiotherapy; 2. To define the diffusion of the different radiotherapy techniques used to treat pelvic nodes and the other features of the radiation treatment; 3. To register prospectively biochemical and clinical failure, prostate cancer deaths and deaths for any cause in the population studied; 4. To register prospectively the toxicity due to radiotherapy and androgen deprivation therapy in patients treated with pelvic nodes radiotherapy; 5. To compare clinical outcomes and toxicities observed in the different clinical and therapeutic subgroups with the corresponding historical data relative to PCa patients treated with radiotherapy with or without elective pelvic nodal irradiation, already available in the existing Italian Society of Radiation Oncology databases; 6. To exploit the collected data to define the need and the features of a prospective randomized trial evaluating the efficacy of elective pelvic nodal irradiation in patients with intermediate/high/very high risk non-metastatic prostate cancer.

Conditions

• Intermediate Risk Prostate Cancer
• High Risk Prostate Cancer

Timeline

• Start date: 2017-02-21
• Primary completion: 2020-02-21
• Completion: 2023-02-21
• First posted: 2017-11-13
• Last updated: 2020-03-18

Locations

1 site across 1 country: Italy