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

Prostate Cancer Clinical Trial

— TALISMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593420
• Other study ID #: A-FR-52014-241
• Status: Completed
• Start date: November 30, 2020
• Est. completion date: December 8, 2022

Study information

• Verified date: December 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 817
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Ipsen Central Contact	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Planned total duration of triptorelin treatment		Baseline, 6 months, 12 months
Secondary	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.	baseline, 6 month, 12 months
Secondary	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.	Baseline
Secondary	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.	12 months
Secondary	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).	baseline, 6 and 12 months
Secondary	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.	baseline
Secondary	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	baseline
Secondary	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).	baseline, 6 months, 12 months