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Completed

NCT Number: NCT06217770

Retrospective Study to Assess Real-Life Use of The Long Acting GnRH Agonist as Prostate Cancer Treatment

It is a retrospective review of the electronic medical record of patients on long-acting triptorelin in Hong Kong.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

Prostate cancer is the second most prevalent cancer in men worldwide. Analogues of natural gonadotrophin releasing hormone (GnRH) are currently available in clinical practice to induce castration in subjects with prostate cancer. While 6 month formulation of Triptorelin has been approved since 2018 for controlling tumor growth in subjects with prostate cancer living in Hong Kong, to date, there are no published clinical data regarding the use and efficacy of the 6 month formulation in Chinese subjects with Chinese heritage. To better understand the real-world experience of long-acting GnRH agonist, there is an unmet need for a retrospective, noninterventional review to collect data regarding the use of the long-acting formulation GnRH in clinical practice as a treatment for prostate cancer. The purpose of this study is to collect data on healthcare characteristics and the treatment patterns in the real-world setting, as well as to understand the profile of the subject population using long-acting formulation GnRH agonist.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of Chinese heritage
  • Prostate cancer patients with the following disease status:
  • High-risk prostate cancer having hormonal therapy as neoadjuvant / adjuvant treatment for prostatectomy or radiotherapy; or
  • Advanced / metastatic prostate cancer treated with long-term hormonal therapy; or
  • After primary therapy (surgery or radiotherapy) with biochemical recurrence; or
  • Castration-resistant prostate cancer status
  • Received at least one dose of 6-month Gonadotropin-releasing Hormone Agonist triptorelin formulation
  • Having at least 6 months of follow-up after administration of the 3-month to 6-month Gonadotropin-releasing Hormone Agonist triptorelin

Exclusion criteria

  • Nil

Treatment and study plan

Primary outcomes

  1. The usage pattern of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in real-life clinical practice

    Time frame: 6 months

    The duration and type of GnRH agonist

Secondary outcomes

  1. The effectiveness of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in inducing and maintaining castration

    Time frame: 6 months

    It is assessed by the PSA , testosterone level

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Ipsen

Registry information

Official study title

Retrospective, Non-interventional Study Assessing the Real-Life Use of The Long- Acting Gonadotropin-releasing Hormone Agonist as A Treatment for Locally Advanced or Meta-static Prostate Cancer in Hong Kong.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Jan 23, 2024

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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