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

Prostate Cancer Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06217770
• Other study ID #: CRE-2023.180
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Ipsen

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20. — View Citation

Weckermann D, Harzmann R. Hormone therapy in prostate cancer: LHRH antagonists versus LHRH analogues. Eur Urol. 2004 Sep;46(3):279-83; discussion 283-4. doi: 10.1016/j.eururo.2004.05.006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The usage pattern of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in real-life clinical practice	The duration and type of GnRH agonist	6 months
Secondary	The effectiveness of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in inducing and maintaining castration	It is assessed by the PSA , testosterone level	6 months