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

• ClinicalTrials.gov Identifier: NCT04593420
• Recruitment Status: Active, not recruiting
• First Posted: October 20, 2020
• Last Update Posted: December 17, 2021
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Study Description

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.

Condition or disease
Prostate Cancer

Study Design

• Study Type: Observational
• Actual Enrollment: 817 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.
• Actual Study Start Date: November 30, 2020
• Estimated Primary Completion Date: November 30, 2022
• Estimated Study Completion Date: November 30, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Proportion of subjects treated continuously with triptorelin for the 12 months [ Time Frame: 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 :

1. Planned total duration of triptorelin treatment [ Time Frame: Baseline, 6 months, 12 months ]
2. Primary reasons of choice of planned total triptorelin treatment duration [ Time Frame: 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.
3. Parameters that influence the planned total duration of triptorelin treatment [ Time Frame: 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.
4. Parameters that influence the modification of the planned total duration of triptorelin treatment [ Time Frame: 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.
5. Formulation and administration route of triptorelin prescribed [ Time Frame: baseline, 6 and 12 months ]
   Formulation and administration route of triptorelin prescribed (monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular).
6. Description of the reasons of choice of formulation and administration route of triptorelin prescribed [ Time Frame: baseline ]
   monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular) at V1, according to the investigator.
7. Parameters that influence the choice of formulation and administration route of triptorelin prescribed [ Time Frame: 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
8. Description and change at each follow-up visit from baseline [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Sampling Method: Probability Sample

Study Population

786 subjects presenting a prostate cancer histologically confirmed and eligible to start triptorelin treatment for at least 12 months will be included in the study. They should also be able to complete a self-questionnaire.

Criteria

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.

Contacts and Locations

Locations

France

Ipsen Central Contact

Paris, France

Sponsors and Collaborators

Ipsen

Investigators

• Study Director: Ipsen Medical Director; Ipsen

More Information

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT04593420
• Other Study ID Numbers: A-FR-52014-241
• First Posted: October 20, 2020
• Last Update Posted: December 17, 2021
• Last Verified: December 2021

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases