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Goserelin Extended-Release Microspheres versus Sustained-Release Implant in Prostate Cancer: Real-World Evidence on Efficacy and Safety

Goserelin Extended-Release Microspheres versus Sustained-Release Implant in Prostate Cancer: Real-World Evidence on Efficacy and Safety

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100634
Enrollment
Unknown
Registered
2025-04-11
Start date
2025-04-17
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

Control group:None
Observation group:None

Sponsors

Aerospace Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. According to the Prostate Cancer Diagnosis and Treatment Guidelines (2022 Edition), patients diagnosed with prostate cancer, 2. Aged between 18-100 years old, 3. Patients with histologically confirmed suitability for endocrine therapy (excluding neoadjuvant endocrine therapy) or local therapy who have received = 1.5 ng/mL, 5. Expected survival period >9 months, 6. Eastern Cooperative Oncology Group (ECOG) performance status score <=2, 7. Treatment with goserelin microspheres or goserelin implants 3.6mg q28d, 8. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with prostate cancer who have previously or are currently receiving hormone therapy 2. Diagnosis or suspected of having hormone-resistant prostate cancer 3. Pituitary resection, adrenalectomy, or pituitary lesions, etc.

Design outcomes

Primary

MeasureTime frame
Percentage of patients with serum testosterone =20ng/dl on day 29 after the first administration of medication.;

Secondary

MeasureTime frame
The cumulative probability of maintaining serum testosterone =50ng/dl from day 29 to day 169;Percentage of patients with serum testosterone =50ng/dl on day 29 after the first administration of medication;The cumulative probability of maintaining serum testosterone =20ng/dl from day 29 to day 169;Assess the incidence of injection site adverse reactions such as pain and bleeding at the patient's injection site at 1, 3, and 6 months after medication administration.;

Countries

China

Contacts

Public ContactLi Chunxing, Liu Hua

Aerospace Center Hospital

2008yuejuan@163.com+86 10 5997 2309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026