NCT03340272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

October 30, 2017

Last Update Submit

March 16, 2020

Conditions

Intermediate Risk Prostate CancerHigh Risk Prostate Cancer

Keywords

prostate cancerpelvic irradiationhormonal treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Radiotherapy techniques used for prostate cancer irradiation

    Four months after the end of the enrollment

  • Outcome of treated prostate cancer

    Three years after the end of the enrollment

  • Outcome of treated prostate cancer

    Three years after the end of the enrollment

  • Outcome of treated prostate cancer

    Three years after the end of the enrollment

  • Outcome of treated prostate cancer

    Three years after the end of the enrollment

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University and Spedali Civili - Brescia

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michela Buglione, Prof

    University and Spedali Civili - Brescia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 13, 2017

Study Start

February 21, 2017

Primary Completion

February 21, 2020

Study Completion

February 21, 2023

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)