To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients

Ipsen510 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

510

Conditions

Prostate Cancer

Interventions

LHRH analoguesDRUG

3-or 6-month formulations

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Hospital A Coruña

A Coruña, Spain

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

Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.

Time frame: 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.

Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

Percentage of patients starting a 6-month formulation at baseline.

The decision to prescribe a LHRH analogue as a 3- or 6-months formulation will be made prior to and independently from the decision to enroll the subject. This decision should be made in accordance with the usual medical practice of the concerned investigator.

Time frame: Baseline

Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients

Time frame: 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

Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.

Time frame: Baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.