Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.

Ipsen1 site in 1 country817 target enrollmentNovember 30, 2020

ConditionsProstate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Ipsen
Enrollment: 817
Locations: 1
Primary Endpoint: Proportion of subjects treated continuously with triptorelin for the 12 months
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France.

Registry

clinicaltrials.gov

Start Date

November 30, 2020

End Date

December 8, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years old
•Histologically confirmed prostate cancer
•Triptorelin to be initiated in its labelled indication for a planned total duration of at least 12 months; decision to start triptorelin was made voluntarily by the physician as part of routine medical practice, prior to the inclusion in the study
•Ability to understand and complete questionnaire,

Exclusion Criteria

•Previously received a hormonal therapy during the last 6 months before inclusion,
•Simultaneously participates in a clinical trial.

Outcomes

Primary Outcomes

Proportion of subjects treated continuously with triptorelin for the 12 months

Time Frame: 12 months

The proportion of subjects treated continuously with triptorelin for the 12 months following treatment initiation, with any formulation and any route of administration. The treatment status (i.e. patient continuously treated / patient not continuously treated) will be assessed according to the investigator's judgment.

Secondary Outcomes

Description of the reasons of choice of formulation and administration route of triptorelin prescribed(baseline)
Formulation and administration route of triptorelin prescribed(baseline, 6 and 12 months)
Description and change at each follow-up visit from baseline(baseline, 6 months, 12 months)
Planned total duration of triptorelin treatment(Baseline, 6 months, 12 months)
Primary reasons of choice of planned total triptorelin treatment duration(baseline, 6 month, 12 months)
Parameters that influence the planned total duration of triptorelin treatment(Baseline)
Parameters that influence the choice of formulation and administration route of triptorelin prescribed(baseline)
Parameters that influence the modification of the planned total duration of triptorelin treatment(12 months)