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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06217770

Enrollment

237

Registered

2024-01-22

Start date

2023-04-01

Completion date

2024-01-04

Last updated

2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Hong Kong

Outcome results