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

January 21, 2024 updated by: Chi Fai NG, Chinese University of Hong Kong

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.

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

High risk prostate cancer patient of Chinese heritage from Prince of Wales Hospital since 1 Sept 2018.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Ipsen

Investigators

  • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

January 4, 2024

Study Completion (Actual)

January 4, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 20, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2023.180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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