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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03193060
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date May 8, 2017
First Posted Date June 20, 2017
Last Update Posted Date March 6, 2020
Actual Study Start Date September 19, 2017
Actual Primary Completion Date December 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2017)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 19, 2017)
  • 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
  • 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
  • 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
  • Incidence of Adverse Events (AEs) [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of Adverse Events (AEs)
  • 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)
  • Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of Adverse Drug Reactions (ADRs)
  • Incidence of AEs leading to treatment discontinuation [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of AEs leading to treatment discontinuation
  • 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
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of Serious Adverse Events (SAEs)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title 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
Brief Summary 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®.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Localized or Locally Advanced Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 9, 2019)
308
Original Estimated Enrollment
 (submitted: June 19, 2017)
500
Actual Study Completion Date December 27, 2019
Actual Primary Completion Date December 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03193060
Other Study ID Numbers D8664R00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date February 2020