Localized or Locally Advanced Prostate Cancer Clinical Trial
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
| Verified date | July 2023 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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®.
| Status | Completed |
| Enrollment | 308 |
| Est. completion date | December 27, 2019 |
| Est. primary completion date | December 27, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 100 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | 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 | Research Site | Jinan | |
| China | Research Site | Langfang | |
| China | Research Site | Nanjing | |
| China | Research Site | Nanjing | |
| China | Research Site | Ningbo | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shijiazhuang | |
| China | Research Site | Urumqi | |
| China | Research Site | Wu Han | |
| China | Research Site | Wuhan | |
| China | Research Site | Wuhan | |
| China | Research Site | Xi'An | |
| China | Research Site | Yantai | |
| China | Research Site | Zhuhai |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PSA level | Change from baseline in PSA level at each visit within 26 weeks during treatment | each visit within 26 weeks during treatment | |
| Primary | Serum Testosterone | Change from baseline in the serum Testosterone at each visit within 26 weeks during treatment | each visit within 26 weeks during treatment | |
| Secondary | Mean serum Testosterone level | Mean serum Testosterone level at baseline and each visit within 26 weeks during treatment | each visit within 26 weeks during treatment | |
| Secondary | Mean serum PSA level | Mean serum PSA level at baseline and each visit within 26 weeks during treatment | each visit within 26 weeks during treatment | |
| Secondary | 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 | each visit within 26 weeks during treatment | |
| Secondary | Incidence of Adverse Events (AEs) | Incidence of Adverse Events (AEs) | each visit within 26 weeks during treatment | |
| Secondary | Incidence of AESI (cardiovascular related AE, sexual related AE) | Incidence of AESI (cardiovascular related AE, sexual related AE) | each visit within 26 weeks during treatment | |
| Secondary | Incidence of Adverse Drug Reactions (ADRs) | Incidence of Adverse Drug Reactions (ADRs) | each visit within 26 weeks during treatment | |
| Secondary | Incidence of AEs leading to treatment discontinuation | Incidence of AEs leading to treatment discontinuation | each visit within 26 weeks during treatment | |
| Secondary | 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 | each visit within 26 weeks during treatment | |
| Secondary | Incidence of Serious Adverse Events (SAEs) | Incidence of Serious Adverse Events (SAEs) | each visit within 26 weeks during treatment |