Status:
UNKNOWN
PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborating Sponsors:
Takeda
Conditions:
Intermediate Risk Prostate Cancer
High Risk Prostate Cancer
Eligibility:
MALE
18+ years
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...
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-no...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03340272
Start Date
February 21 2017
End Date
February 21 2023
Last Update
March 18 2020
Active Locations (1)
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1
University and Spedali Civili - Brescia
Brescia, Italy, 25123