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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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

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

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

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)

September 19, 2017

Primary Completion (Actual)

December 27, 2019

Study Completion (Actual)

December 27, 2019

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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