Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Prostate Cancer | — | UNRESOLVED | — |
| Intermediate Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Practice of pelvic irradiation
- timeFrame
- Four months after the end of the enrollment
- description
- 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 outcomes (7)
- measure
- Radiotherapy techniques used for prostate cancer irradiation
- timeFrame
- Four months after the end of the enrollment
- description
- 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
- measure
- Outcome of treated prostate cancer
- timeFrame
- Three years after the end of the enrollment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available