PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.

NCT ID: NCT03340272

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2023-02-21

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Men older than or aged 18 years;
• Histologically confirmed intermediate, high or very high risk prostate cancer patients (NCCN classification: Intermediate Risk T2b and T2c or Gleason Score 7 or Prostate specific antigen (PsA) value between 10 and 20 ng/mL; High risk: T3a or Gleason score 8-10 or PSA > 20 ng/ml; Very high risk: T3b-T4 or patients with multiple adverse risk factors reported in the high risk category that may be shifted in the very high risk group
• Patients eligible for -and actually submitted to- radical radiotherapy treatment (+/- androgen deprivation) or adjuvant radiotherapy treatment after surgery (radical prostatectomy +/- pelvic lymphadenectomy);
• No other synchronous or previous malignant tumor other than skin basal cell carcinoma;
• Patients able to understand and sign the appropriate informed consent;
• Patients able to fill the QoL questionnaire;

Exclusion Criteria

• Patients aged less than 18;
• Patients not eligible for -and actually not submitted to- radical radiotherapy treatment (+/- androgen deprivation) or adjuvant radiotherapy treatment after surgery (radical prostatectomy +/- pelvic lymphadenectomy);
• Low risk prostate cancer (<T2b and T2c or < Gleason Score 7 or PSA value < 10 ng/mL);
• Patients with synchronous or previous malignancy other than skin basal cell carcinoma;
• Patients able to understand and sign the appropriate informed consent (IC) who decide not to subscribe IC;
• Patients not able to understand and sign the appropriate informed consent (IC)
• Patients unable to fill the QoL questionnaire.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Michela Buglione

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michela Buglione, Prof

Role: PRINCIPAL_INVESTIGATOR

University and Spedali Civili - Brescia

Locations

University and Spedali Civili - Brescia

Brescia, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NP2283

Identifier Type: -

Identifier Source: org_study_id