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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

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ClinicalTrials.gov Identifier: NCT03193060
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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®.

Condition or disease
Localized or Locally Advanced Prostate Cancer

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.


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Study Type : Observational
Actual Enrollment : 308 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Incidence of Adverse Events (AEs) [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of Adverse Events (AEs)

  5. 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)

  6. Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of Adverse Drug Reactions (ADRs)

  7. Incidence of AEs leading to treatment discontinuation [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of AEs leading to treatment discontinuation

  8. 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

  9. Incidence of Serious Adverse Events (SAEs) [ Time Frame: each visit within 26 weeks during treatment ]
    Incidence of Serious Adverse Events (SAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193060


  Show 23 Study Locations
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03193060     History of Changes
Other Study ID Numbers: D8664R00001
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents