Clinical trial NCT03340272: PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.
Official title: PROspective Multicenter Observational Study on Elective Pelvic Nodes (PRO-EPI) Irradiation in Patients With Intermediate/High/Very High Risk Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intermediate Risk Prostate Cancer
High Risk Prostate Cancer
Keywords: prostate cancer
pelvic irradiation
hormonal treatment
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2017-11-13
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for prostate cancer without or after surgery, with or without association of hormonal treatment.

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.

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.

Primary outcomes:
measure: Practice of pelvic irradiation
timeFrame: Four months after the end of the enrollment
Secondary outcomes:
measure: Radiotherapy techniques used for prostate cancer irradiation
timeFrame: Four months after the end of the enrollment
measure: Outcome of treated prostate cancer
timeFrame: Three years after the end of the enrollment
measure: Outcome of treated prostate cancer
timeFrame: Three years after the end of the enrollment
measure: Outcome of treated prostate cancer
timeFrame: Three years after the end of the enrollment
measure: Outcome of treated prostate cancer
timeFrame: Three years after the end of the enrollment
measure: Toxicity of treated prostate cancer
timeFrame: Within 6 months after the end of the treatment
measure: Comparison of toxicity and outcome in the different groups
timeFrame: Three years after the end of the enrollment
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: University and Spedali Civili - Brescia
Study officials:
affiliation: University and Spedali Civili - Brescia
name: Michela Buglione, Prof
role: PRINCIPAL_INVESTIGATOR
References: