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Completed

NCT Number: NCT04593420

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ipsen Central Contact

Paris, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Acronym: TALISMAN

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2020
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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