Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Goserelin

Bicalutamide

Antineoplastic Agents, Hormonal

Intramuscular injections of LY01005 3.6 mg every 28 days for a maximum of 3 consecutive doses.

Subcutaneous injections of ZOLADEX® 3.6 mg every 28 days for a maximum of 3 consecutive doses.

LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.

LY01005 3.6 mg

ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.

ZOLADEX® 3.6 mg

Dingwei Ye

This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with prostate cancer.

This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial using non-inferior design. A total of 290 patients with prostate cancer who were suitable for endocrine therapy were enrolled into the screening period from D-21 to D-10 before administration. Eligible subjects were treated with bicalutamide tablets (Casodex®, 50 mg/day) from D-10 (± 3d) before administration and randomized in a 1:1 ratio to receive LY01005 3.6 mg or ZOLADEX® 3.6 mg after completion of pretreatment. All subjects were administered once every 28 days for three doses until intolerable toxicity, disease progression requiring other anti-tumor treatments, withdrawal of consent, loss to follow-up, death or the end of the whole study. Blood samples were collected at the specified time points of the screening period, before/behind each dose to detect serum testosterone, LH, FSH and PSA. Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) was conducted as required in the protocol.

Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®

A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Prostate Cancer

The percentage of subjects with serum testosterone ≤20 ng/dL (0.7 nmol/L) on Day 29 after the first dose, and the cumulative percentage of subjects with the maintenance of serum testosterone ≤20 ng/dL (0.7 nmol/L) from Day 29 to Day 85.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®	NCT04563936	Prostate Cancer	LY01005 3.6 mg ZOLADEX® 3.6 mg	50 Years -	Luye Pharma Group Ltd.
Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®	NCT04563936	Prostate Cancer	LY01005 3.6 mg ZOLADEX® 3.6 mg	50 Years -	Luye Pharma Group Ltd.

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