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

• ClinicalTrials.gov Identifier: NCT03340272
• Recruitment Status: Active, not recruiting
• First Posted: November 13, 2017
• Last Update Posted: March 18, 2020
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Collaborator: Takeda
• Information provided by (Responsible Party): Michela Buglione, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years
• Official Title: PROspective Multicenter Observational Study on Elective Pelvic Nodes (PRO-EPI) Irradiation in Patients With Intermediate/High/Very High Risk Prostate Cancer
• Actual Study Start Date: February 21, 2017
• Actual Primary Completion Date: February 21, 2020
• Estimated Study Completion Date: February 21, 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Practice of pelvic irradiation [ Time Frame: Four months after the end of the enrollment ]
   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

Secondary Outcome Measures :

1. Radiotherapy techniques used for prostate cancer irradiation [ Time Frame: Four months after the end of the enrollment ]
   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
2. Outcome of treated prostate cancer [ Time Frame: Three years after the end of the enrollment ]
   Biochemical relapse free survival
3. Outcome of treated prostate cancer [ Time Frame: Three years after the end of the enrollment ]
   Clinical relapse free survival
4. Outcome of treated prostate cancer [ Time Frame: Three years after the end of the enrollment ]
   Disease specific free survival
5. Outcome of treated prostate cancer [ Time Frame: Three years after the end of the enrollment ]
   Overall survival
6. Toxicity of treated prostate cancer [ Time Frame: Within 6 months after the end of the treatment ]
   register, using CTCAE v.4 acute and late urinary and rectal toxicities in the groups of patients treated with/without pelvic irradiation.
7. Comparison of toxicity and outcome in the different groups [ Time Frame: Three years after the end of the enrollment ]
   Using chi-square test compare toxicities and clinical outcome in the different groups of patients.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

Italy

University and Spedali Civili - Brescia

Brescia, Italy, 25123

Sponsors and Collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Takeda

Investigators

• Principal Investigator: Michela Buglione, Prof; University and Spedali Civili - Brescia

  Study Documents (Full-Text)

Documents provided by Michela Buglione, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia:

Study Protocol and Statistical Analysis Plan  [PDF] January 18, 2016

More Information

Additional Information:

• Responsible Party: Michela Buglione, Prof, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• ClinicalTrials.gov Identifier: NCT03340272
• Other Study ID Numbers: NP2283
• First Posted: November 13, 2017
• Last Update Posted: March 18, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michela Buglione, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia:

prostate cancer; pelvic irradiation; hormonal treatment

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases