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

NCT04593420 | Completed

• 1 other identifier: A-FR-52014-241
• Study Type: observational
• Target: 817
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Parameters that influence the planned total duration of triptorelin treatment

  Baseline

• Parameters that influence the modification of the planned total duration of triptorelin treatment

  12 months

• Formulation and administration route of triptorelin prescribed

  baseline, 6 and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• At least 18 years old
• Histologically confirmed prostate cancer
• Ability to understand and complete questionnaire,

You may not qualify if:

• Simultaneously participates in a clinical trial.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Ipsen Central Contact

Paris, France

Location

Related Publications (1)

• Lebret T, Crehange G, Pello-Leprince-Ringuet N, Perrot V, Rigaud J. Treatment of aggressive prostate cancer with triptorelin in real life in France: the TALISMAN study. Ther Adv Urol. 2025 Oct 15;17:17562872251382970. doi: 10.1177/17562872251382970. eCollection 2025 Jan-Dec.

  PMID: 41122488 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: November 30, 2020
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Locations

FR (1)