A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer

July 13, 2023 updated by: AstraZeneca
This study is a multi-centre, prospective observational study. The study plans to enrol 500 patients with localized or locally advanced prostate cancer who are eligible and intended to be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical sites in China. The effectiveness and safety data will be collected at baseline and each visit within 26 weeks after treatment of Zoladex®.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Androgen Deprivation Therapy (ADT) is a standard treatment for locally advanced or metastatic prostate cancer. It is also increasingly used in patients with high-risk localized prostate cancer or in patients with prostate-specific antigen (PSA) relapse after local therapy.

The luteinizing hormone-releasing hormone (LHRH) agonists, such as goserelin acetate(Zoladex®), have provided an effective and reversible means of suppressing androgen level. Zoladex® was originally formulated as a 3.6mg depot injection. Goserelin acetate 10.8-mg depot, given once every 3 months, is pharmacodynamically equivalent to 3 consecutive monthly injections of the goserelin acetate 3.6-mg depot, offers a more convenient and cost-effective dosing regimen for patients.

Goserelin acetate 10.8-mg depot has been available in China since 2012. However, data on the effectiveness and safety of the long-acting depot of Zoladex® (goserelin acetate depot) 10.8mg specifically in a Chinese population is limited. A "real-world" observational study is proposed to establish the effectiveness and safety profile of Zoladex ® 10.8mg in Chinese patients with localized or locally advanced prostate cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

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

  • China
      • Beijing, China, 100034
        • Research Site
      • Beijing, China, 100191
        • Research Site
      • Chengdu, China, 610072
        • Research Site
      • Foshan, China, 528000
        • Research Site
      • Guangdong, China
        • Research Site
      • Guangzhou, China, 510120
        • Research Site
      • Guangzhou, China, 510530
        • Research Site
      • Hangzhou, China, 310022
        • Research Site
      • Harbin, China, 150081
        • Research Site
      • Jinan, China, 250012
        • Research Site
      • Jinan, China, 250021
        • Research Site
      • Langfang, China
        • Research Site
      • Nanjing, China, 210009
        • Research Site
      • Nanjing, China, 210029
        • Research Site
      • Ningbo, China, 315000
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200433
        • Research Site
      • Shijiazhuang, China
        • Research Site
      • Urumqi, China, 830054
        • Research Site
      • Wu Han, China, 430060
        • Research Site
      • Wuhan, China, CN-430030
        • Research Site
      • Wuhan, China, 430022
        • Research Site
      • Xi'An, China
        • Research Site
      • Yantai, China, 264000
        • Research Site
      • Zhuhai, China, 519000
        • Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients with localized or locally advanced prostate cancer who are prescribed Zoladex® (goserelin acetate implant) 10.8 mg or 3.6 mg as monotherapy or in combination with androgen blockade (CAB), either as first line treatment or adjuvant therapy to radical prostatectomy (RP) are eligible to be the study target population.

Description

Inclusion Criteria:

  1. Ability to provide informed consent, complete all study assessments and have complete medical record;
  2. Male aged 18 years and over;
  3. Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;
  4. Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);
  5. More than 26 weeks' life expectancy;

Exclusion Criteria:

  1. Patients who are planned to receive radiation therapy;
  2. Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;
  3. Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PSA level
Time Frame: each visit within 26 weeks during treatment
Change from baseline in PSA level at each visit within 26 weeks during treatment
each visit within 26 weeks during treatment
Serum Testosterone
Time Frame: each visit within 26 weeks during treatment
Change from baseline in the serum Testosterone at each visit within 26 weeks during treatment
each visit within 26 weeks during treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean serum Testosterone level
Time Frame: each visit within 26 weeks during treatment
Mean serum Testosterone level at baseline and each visit within 26 weeks during treatment
each visit within 26 weeks during treatment
Mean serum PSA level
Time Frame: each visit within 26 weeks during treatment
Mean serum PSA level at baseline and each visit within 26 weeks during treatment
each visit within 26 weeks during treatment
Number of patients with serum Testosterone less than 50 ng/ml
Time Frame: each visit within 26 weeks during treatment
Number of patients with serum Testosterone less than 50 ng/ml at each visit within 26 weeks during treatment
each visit within 26 weeks during treatment
Incidence of Adverse Events (AEs)
Time Frame: each visit within 26 weeks during treatment
Incidence of Adverse Events (AEs)
each visit within 26 weeks during treatment
Incidence of AESI (cardiovascular related AE, sexual related AE)
Time Frame: each visit within 26 weeks during treatment
Incidence of AESI (cardiovascular related AE, sexual related AE)
each visit within 26 weeks during treatment
Incidence of Adverse Drug Reactions (ADRs)
Time Frame: each visit within 26 weeks during treatment
Incidence of Adverse Drug Reactions (ADRs)
each visit within 26 weeks during treatment
Incidence of AEs leading to treatment discontinuation
Time Frame: each visit within 26 weeks during treatment
Incidence of AEs leading to treatment discontinuation
each visit within 26 weeks during treatment
Proportion of patients with serum Testosterone less than 50 ng/ml
Time Frame: each visit within 26 weeks during treatment
Proportion of patients with serum Testosterone less than 50 ng/ml at each visit within 26 weeks during treatment
each visit within 26 weeks during treatment
Incidence of Serious Adverse Events (SAEs)
Time Frame: each visit within 26 weeks during treatment
Incidence of Serious Adverse Events (SAEs)
each visit within 26 weeks during treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8664R00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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