Trials / Recruiting
RecruitingNCT06385847
To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- The First Affiliated Hospital of Xiamen University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer
Detailed description
Androgen Deprivation Therapy (ADT) is an important systemic therapy for prostate cancer, which plays a vital role in the treatment of various stages of prostate cancer. Gonadotropin-releasing hormone (GnRH) agonists are the most commonly used ADT treatment，including leuprolide, goserelin, and triptorelin. The goserelin implant (Zoladex®) 3.6 mg is administered subcutaneously every 28 days into the anterior abdominal wall using a pre-filled syringe with a 16G needle (outer diameter 1.6 mm), while the Goserelin microsphere (LY01005) 3.6 mg is administered every 28 days by intramuscular injection using a 21G injection needle (outer diameter 0.8 mm). Phase III study (NCT04563936) have confirmed the similar efficacy and safety between the two drugs, but patient preference for both are unknown. The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zoladex | Patients received 3.6 mg subcutaneous Zoladex |
| DRUG | LY01005 | Patients received 3.6 mg intramuscular LY01005 |
Timeline
- Start date
- 2024-05-01
- Primary completion
- 2025-05-01
- Completion
- 2025-12-01
- First posted
- 2024-04-26
- Last updated
- 2024-04-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06385847. Inclusion in this directory is not an endorsement.