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.
Study Type
OBSERVATIONAL
Enrollment
817
Ipsen Central Contact
Paris, France
Proportion of subjects treated continuously with triptorelin for the 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.
Time frame: 12 months
Planned total duration of triptorelin treatment
Time frame: Baseline, 6 months, 12 months
Primary reasons of choice of planned total triptorelin treatment duration
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.
Time frame: baseline, 6 month, 12 months
Parameters that influence the planned total duration of triptorelin treatment
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.
Time frame: Baseline
Parameters that influence the modification of the planned total duration of triptorelin treatment
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.
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Time frame: 12 months
Formulation and administration route of triptorelin prescribed
Formulation and administration route of triptorelin prescribed (monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular).
Time frame: baseline, 6 and 12 months
Description of the reasons of choice of formulation and administration route of triptorelin prescribed
monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular) at V1, according to the investigator.
Time frame: baseline
Parameters that influence the choice of formulation and administration route of triptorelin prescribed
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
Time frame: baseline
Description and change at each follow-up visit from baseline
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).
Time frame: baseline, 6 months, 12 months