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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT04593420
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Study Start: 2020-11-30
• Status Verified: 2022-12
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 817

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,

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects treated continuously with triptorelin for the 12 months	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 Outcome Measures

Name	Time	Method
Description of the reasons of choice of formulation and administration route of triptorelin prescribed	baseline	monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular) at V1, according to the investigator.
Formulation and administration route of triptorelin prescribed	baseline, 6 and 12 months	Formulation and administration route of triptorelin prescribed (monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular).
Description and change at each follow-up visit from baseline	baseline, 6 months, 12 months	Description and change at each follow-up visit (V2, V3) from baseline (V1) in each of the 6 sub-scales of the QLQ-PR25 questionnaire (urinary symptoms, incontinence aid, bowel symptoms; treatment related symptoms, sexual activity, sexual functioning). QLQ-PR25 score is distributed from 1 (not at all) to 4 (very much).
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	Description of the primary reason of choice of planned total triptorelin treatment duration declared by the investigator, at V1; and at V2 and V3 if the planned total duration is modified.
Parameters that influence the planned total duration of triptorelin treatment	Baseline	Identification of parameters that influence the planned total duration of triptorelin treatment including but not limited to the following parameters: Circumstance of prescription, Prostate Cancer (PCa) aggressiveness criteria, Prior PCa treatments, Concomitant PCa treatments, Subject's characteristics: age, weight, Karnofsky score, specific comorbidities and concomitant treatments, genetic predisposition.
Parameters that influence the choice of formulation and administration route of triptorelin prescribed	baseline	Identification of parameters that influence the choice of formulation and administration route of triptorelin prescribed (monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular) at V1 including but not limited to the following parameters: Disease with symptoms, total planned duration of treatment, highly evolutive disease, heavy PCa concomitant treatment, physical frailty of subjects, psychological context of subjects, potential impact on compliance, subject afraid of injection, anticoagulant treatment, BMI, Preferred investigator formulation/route
Parameters that influence the modification of the planned total duration of triptorelin treatment	12 months	Identification of parameters that influence the modification (if any) of the planned total duration of triptorelin treatment including but not limited to the following parameters: PCa aggressiveness criteria at 12 months (PSA, concomitant treatments for prostate cancer, symptoms, metastases assessment), Subject's characteristics: age, weight, Karnofsky score, specific comorbidities and concomitant treatments, genetic predisposition at baseline, follow up assessments, care pathway.

Trial Locations

Locations (1)

Ipsen Central Contact; 🇫🇷 Paris, France