PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation. (PRO-EPI)

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

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.

Study Overview

• Status: Unknown
• Conditions: Intermediate Risk Prostate Cancer; High Risk Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25123
    • University and Spedali Civili - Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for prostate cancer without or after surgery, with or without association of hormonal treatment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Practice of pelvic irradiation	Evaluate the number of patients treated with RT on pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer	Four months after the end of the enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiotherapy techniques used for prostate cancer irradiation	Analyze the number of patients treated with 3Dconformal Radiotherapy (3DCRT), Intensity Modulated Radiation Therapy (IMRT), Volumetric arch Therapy (VMAT), Tomotherapy, respectively with/without Image Guided Radiotherapy (IGRT) for pelvic irradiation	Four months after the end of the enrollment
Outcome of treated prostate cancer	Biochemical relapse free survival	Three years after the end of the enrollment
Outcome of treated prostate cancer	Clinical relapse free survival	Three years after the end of the enrollment
Outcome of treated prostate cancer	Disease specific free survival	Three years after the end of the enrollment
Outcome of treated prostate cancer	Overall survival	Three years after the end of the enrollment
Toxicity of treated prostate cancer	register, using CTCAE v.4 acute and late urinary and rectal toxicities in the groups of patients treated with/without pelvic irradiation.	Within 6 months after the end of the treatment
Comparison of toxicity and outcome in the different groups	Using chi-square test compare toxicities and clinical outcome in the different groups of patients.	Three years after the end of the enrollment

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Collaborators: Takeda
• Investigators: Principal Investigator: Michela Buglione, Prof, University and Spedali Civili - Brescia

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): February 21, 2020
• Study Completion (Anticipated): February 21, 2023

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: prostate cancer; hormonal treatment; pelvic irradiation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NP2283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No