Factors Affecting Androgen Deprivation Therapy Choice in Prostate Cancer Patients

May 31, 2023 updated by: Chi Fai NG, Chinese University of Hong Kong

A Survey to Investigate Possible Factors That Will Affect the Choice of Androgen Deprivation Therapy in Prostate Cancer Patients

The objective of this study is to investigate possible factors that will affect the choice of androgen deprivation therapy in prostate cancer patients. This is a cross-sectional study performed in Prince of Wales Hospital in Hong Kong. One hundred patients will be recruited for this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence of prostate cancer in Hong Kong almost tripled between 1996 and 2010, with the highest increased incidence rate in total forms of malignancy. The incidence of prostate cancer in Hong Kong increased up to 28.9 per 100,000 men in 2017 (Age-standardized rate) (Hong Kong Cancer Registry 2017) and ranked third in all men cancers in Hong Kong. Certain environmental elements have had an effect on the increased rate of prostate cancer, including the transition to Western dietary habits and an aging population because of the rise in average life expectancy. In addition to environmental causes, the medical development of laboratory diagnoses and wide prostate-specific antigen usage in Hong Kong have also contributed to the increase in diagnosis of prostate cancer in recent years. Certainly, the efforts from different health bodies in public education about the condition have helped to raise public awareness about the condition, which also increase the pick-up of early disease in Hong Kong.

Androgen deprivation treatment (ADT) has become the standard treatment for metastatic prostate cancer in the past decades. Androgen deprivation can be achieved by three main modalities, namely bilateral orchidectomy, gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist. Apart from injectable ADT, oral GnRH antagonist has been approved recently. ADT can be different in terms of mechanism of action, route of drug administration (injection vs oral), site of injection and frequency of drug administration. Each different formulation may contribute to patient's choice on their drug usage [1-3]. However, information regarding the preference of choice and factors affecting the choice of ADT formulation were not available in the literature. Therefore, in this study, possible factors that will affect patient's choice of ADT, reason and preference on their ADT choice will be investigated.

The objective of this study is to investigate possible factors that will affect patient's choice of ADT therapy. This is a cross-sectional study performed in Prince of Wales Hospital in Hong Kong. One hundred patients will be recruited for this study.

After obtaining informed consent, trained research staffs will assist the subjects to perform this cross-sectional survey. Information related to patients' background (including, but not limited to: age, educational level, work-status, living situation), disease background (stage of disease), concomitant drug usage & administrative frequency, preference on drug usage (ADT vs injection; frequency of drug administration), history of ADT usage, reason and preference on their ADT choice, will be collected from the survey.

Study Type

Observational

Enrollment (Actual)

100

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with prostate cancer in Prince of Wales Hospital will be identified in specialist clinics and then enrolled to the study,

Description

Inclusion Criteria:

  • Prostate cancer only happens in male patients
  • Patients who are currently receiving at least one dose of LHRH agonist or antagonist, as androgen deprivation therapy
  • Patients who are willing to consent and participate in this study

Exclusion Criteria:

  • Patients who received bilateral orchidectomy as androgen deprivation therapy
  • Patients who, in the opinion of investigators, are not able to comprehend about the study questions

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate Cancer
Patients diagnosed with prostate cancer
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Possible factors that will affect patient's choice of ADT therapy
Time Frame: 1 year
Possible factors that will affect patient's choice of ADT therapy
1 year

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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)

January 7, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2021.492

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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