Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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®.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized or Locally Advanced Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- PSA level
- timeFrame
- each visit within 26 weeks during treatment
- description
- Change from baseline in PSA level at each visit within 26 weeks during treatment
- measure
- Serum Testosterone
- timeFrame
- each visit within 26 weeks during treatment
- description
- Change from baseline in the serum Testosterone at each visit within 26 weeks during treatment
Secondary outcomes (9)
- measure
- Mean serum Testosterone level
- timeFrame
- each visit within 26 weeks during treatment
- description
- Mean serum Testosterone level at baseline and each visit within 26 weeks during treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available