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

NCT04563936 | Completed Phase 3

• 1 other identifier: LY01005/CT-CHN-302
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; LY01005; Efficacy; Safety

Outcome Measures

Primary Outcomes (2)

• The percentage of subjects with serum testosterone ≤50 ng/dL (1.735 nmol/L) on Day 29 after the first dose.

  Day 29 after the first dose

• The cumulative percentage of subjects with the maintenance of serum testosterone ≤50 ng/dL (1.735 nmol/L) from Day 29 to Day 85.

  from Day 29 to Day 85

Secondary Outcomes (10)

• Significant Castration Rate

  from Day 29 to Day 85

• The percentage of subjects with an acute increase in serum testosterone above castrate levels within 72 hours following repeated dosing.

  within 72 hours following the second and third administration

• Percentage changes compared to baseline in serum LH level after administration.

  from baseline to Day 85

• Changes in serum LH level after administration.

  from baseline to Day 85

• Percentage changes compared to baseline in serum FSH level after administration.

  from baseline to Day 85

Study Arms (2)

LY01005 3.6 mg

EXPERIMENTAL

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

Drug: LY01005 3.6 mg

ZOLADEX® 3.6 mg

ACTIVE COMPARATOR

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

Drug: ZOLADEX® 3.6 mg

Interventions

LY01005 3.6 mg DRUG

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.

Also known as: Goserelin Acetate Sustained-Release Microspheres for Injection

LY01005 3.6 mg

ZOLADEX® 3.6 mg DRUG

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.

Also known as: goserelin acetate implant 3.6 mg

ZOLADEX® 3.6 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older.
• Patients with pathological confirmed prostate cancer suitable for endocrine therapy (except for neoadjuvant endocrine therapy), including those who are suitable for endocrine therapy (such as patients with biochemical recurrence after adjuvant endocrine therapy and radical therapy) following radical therapy.
• Serum testosterone level ≥ 1.50 ng/mL (5.21 nmol/L) at the screening visit (based on the test results of research centers).
• Life expectancy of at least 9 months.
• ECOG score of ≤ 2.
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, white blood cell count ≥ 3 x 10\^9/L, and hemoglobin ≥ 90 g/L at the screening visit.
• Total bilirubin (TBIL) ≤ 1.5×ULN, both ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases) at the screening visit.
• Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 30 mL/min at the screening visit.
• Patients who voluntarily sign an IRB-approved informed consent form before the screening visit, are willing to abide by the restrictions of the study, and complete the prescribed examinations.

You may not qualify if:

• Patients with prostate cancer who receive previous or ongoing endocrine therapy (surgical castration or other endocrine therapy including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, etc.), except for patients with prostate cancer undergoing prostatectomy, radiotherapy or cryotherapy who have received neoadjuvant/adjuvant endocrine therapy for no more than 6 months and discontinued the above therapy more than 6 months before screening.
• Has received prostatic surgery within 4 weeks prior to the Screening Visit, or plan to receive surgical treatment during the trial.
• Patients with confirmed or suspected hormone-resistant prostate cancer.
• Has previously received hypophysectomy or adrenalectomy, or who have pituitary lesions.
• Has received 5-α reductase inhibitors (finasteride, dutasteride, eridasteride, etc.) within 1 month before the first dose.
• Has previously received goserelin.
• Has received an investigational drug, an investigational biological product or an investigational medical device, and discontinued within 1 month or 5 half-lives of the corresponding drug before the screening visit, whichever is longer.
• History of severe asthma, anaphylaxis, or severe urticaria and/or angioedema.
• History or presence of another malignancy, other than surgically removed squamous/basal cell carcinoma of the skin, within the last 5 years.
• History of the following medical histories within 6 months: myocardial infarction, unstable angina, coronary revascularization, New York Heart Association (NYHA) class ≥ II cardiac insufficiency, severe unstable arrhythmia; Or the presence of arrhythmia requiring treatment at the screening period.
• Hypertensive patients with poor blood pressure control after medication (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg at the screening visit).
• Has received coumarin anticoagulants.
• Patients with type 1 diabetes or type 2 diabetes with poor glycemic control (glycosylated hemoglobin \> 8% at the screening visit).
• Has congenital long QT syndrome or QT/QTc interval prolongation (QTc ≥ 450 ms) at the screening visit; Or has received drugs that may prolong QT/QTc interval at the screening visit.
• Alcoholics, drug addicts or drug abusers.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Related Publications (1)

• Gu C, Wang Z, Lin T, Liu Z, Han W, Zhang X, Liang C, Liu H, Yu Y, Xu Z, Liu S, Wang J, Jia L, Yao X, Liao W, Fu C, Tan Z, He G, Zhu G, Fan R, Yang W, Chen X, Liu Z, Zhong L, Shi B, Ding D, Chen S, Wei J, Yao X, Chen M, Lu Z, Xie Q, Hu Z, Wang Y, Guo H, Fan T, Liang Z, Chen P, Wang W, Xu T, Li C, Xing J, Liao H, He D, Wu Z, Yu J, Feng Z, Yang M, Dou Q, Zeng Q, Li Y, Gou X, Zhou G, Wang X, Zhu R, Zhang Z, Zhang B, Tan W, Qu X, Sun H, Gan T, Ye D. Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial. Chin Med J (Engl). 2023 May 20;136(10):1207-1215. doi: 10.1097/CM9.0000000000002638. Epub 2023 Apr 3.

  PMID: 37010251 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Injections; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Dingwei Ye

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: January 6, 2020
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)