Prostate CancerNCT06217770
Retrospective Study to Assess Real-Life Use of The Long Acting GnRH Agonist as Prostate Cancer Treatment
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
It is a retrospective review of the electronic medical record of patients on long-acting triptorelin in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 237 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2023to 4 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: High risk prostate cancer patient of Chinese heritage from Prince of Wales Hospital since 1 Sept 2018.
Who may be able to join
- 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
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
About this study
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.
It is a retrospective review of the electronic medical record of patients on long-acting triptorelin in Hong Kong.
Read the 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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Apr 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Principal investigator, Chi Fai NG, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217770
- Sponsor's protocol ID
- CRE-2023.180
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20.
PubMed 31068988Weckermann 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.
PubMed 15306097
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06217770
- Acronym / sponsor ID
- CRE-2023.180
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High risk prostate cancer patient of Chinese heritage from Prince of Wales Hospital since 1 Sept 2018.
Key inclusion criteria (8 listed)
- Patients of Chinese heritage
- Prostate cancer patients with the following disease 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
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The effectiveness of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in inducing and maintaining castration
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 31068988Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20.
- Background: PubMed 15306097Weckermann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai NG, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The usage pattern of the long-acting Gonadotropin-releasing Hormone Agonist agonist triptorelin in real-life clinical practice (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.