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

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.

Inclusion Criteria:

1. Male patients older than 18 years

2. Histologically confirmed prostate adenocarcinoma

3. Suitable for ADT treatment

4. ECOG≤2

5. Prior treatment without GnRH agonists

6. Expected survival >1 year

7. Good compliance

8. Adequate organ or bone marrow function as evidenced by:

   • Hemoglobin >/= 10 g/dL
   • Absolute neutrophil count >/=1.5 x 109/L,
   • Platelet count >/=100 x 109/L,
   • AST/SGOT and/or ALT/SGPT \