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®.
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
308
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Foshan, China
Research Site
Guangdong, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Harbin, China
Research Site
Jinan, China
...and 15 more locations
PSA level
Change from baseline in PSA level at each visit within 26 weeks during treatment
Time frame: each visit within 26 weeks during treatment
Serum Testosterone
Change from baseline in the serum Testosterone at each visit within 26 weeks during treatment
Time frame: each visit within 26 weeks during treatment
Mean serum Testosterone level
Mean serum Testosterone level at baseline and each visit within 26 weeks during treatment
Time frame: each visit within 26 weeks during treatment
Mean serum PSA level
Mean serum PSA level at baseline and each visit within 26 weeks during treatment
Time frame: each visit within 26 weeks during treatment
Number of patients with serum Testosterone less than 50 ng/ml
Number of patients with serum Testosterone less than 50 ng/ml at each visit within 26 weeks during treatment
Time frame: each visit within 26 weeks during treatment
Incidence of Adverse Events (AEs)
Incidence of Adverse Events (AEs)
Time frame: each visit within 26 weeks during treatment
Incidence of AESI (cardiovascular related AE, sexual related AE)
Incidence of AESI (cardiovascular related AE, sexual related AE)
Time frame: each visit within 26 weeks during treatment
Incidence of Adverse Drug Reactions (ADRs)
Incidence of Adverse Drug Reactions (ADRs)
Time frame: each visit within 26 weeks during treatment
Incidence of AEs leading to treatment discontinuation
Incidence of AEs leading to treatment discontinuation
Time frame: each visit within 26 weeks during treatment
Proportion of patients with serum Testosterone less than 50 ng/ml
Proportion of patients with serum Testosterone less than 50 ng/ml at each visit within 26 weeks during treatment
Time frame: each visit within 26 weeks during treatment
Incidence of Serious Adverse Events (SAEs)
Incidence of Serious Adverse Events (SAEs)
Time frame: each visit within 26 weeks during treatment
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