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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT06217770
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-04
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-20
• Last Update Submitted: 2024-01-21
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 237

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The usage pattern of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in real-life clinical practice	6 months	The duration and type of GnRH agonist

Secondary Outcome Measures

Name	Time	Method
The effectiveness of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in inducing and maintaining castration	6 months	It is assessed by the PSA , testosterone level

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong