A Prospective Post Marketing Non Interventional Study to Evaluate the Criteria on Which Renewal of LHRH Analogue Treatment is Made in Patients With Prostate Cancer Locally Advanced or Metastatic.

Ipsen27 sites in 1 country510 target enrollmentJuly 13, 2017

ConditionsProstate Cancer

DrugsLHRH analogues

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Ipsen
Enrollment: 510
Locations: 27
Primary Endpoint: Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed

Registry

clinicaltrials.gov

Start Date

July 13, 2017

End Date

June 14, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy with a 3 or 6 month LHRH analogue including those requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with radiotherapy
•Patients having provided written informed consent
•Patients mentally fit for completing a self-administrated questionnaire

Exclusion Criteria

•Patients participating in another clinical study at the time of inclusion
•Patients with another severe malignant disease
•Life expectancy of less than 12 months
•Patients already treated with a LHRH analogue within the last year

Outcomes

Primary Outcomes

Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).

Time Frame: First follow-up visit (occurs 3 to 6 months from baseline)

Secondary Outcomes

Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.(Baseline)
Percentage of patients starting a 6-month formulation at baseline.(Baseline)
Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)