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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Zoladex; Drug: LY01005

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xuegang Wang, doctor; Phone Number: 15960263909; Email: stefwxg@163.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The first affiliated hospital of xiamen university
      • Contact: Xuegang Wang, doctor; Phone Number: 15960263909; Email: stefwxg@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 </=1.5 x ULN;
   • Total bilirubin </=1.5 x ULN,
   • Serum creatinine </=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded

Exclusion Criteria:

1. Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for < 6 months and discontinued for more than 6 months were allowed
2. Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions
3. A history of cardiovascular events, uncontrolled hypertension, gastrointestinal disease that interferes with treatment absorption, active viral hepatitis, or human immunodeficiency infection (HIV) within the past 6 months
4. Any medical conditions that the investigators believe make the patient ineligible to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Zo-LY; Arm Zo-LY: Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles, followed by LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles	Drug: Zoladex; Patients received 3.6 mg subcutaneous Zoladex; Drug: LY01005; Patients received 3.6 mg intramuscular LY01005
Other: LY-Zo; Arm LY-Zo: LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles, followed by Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles	Drug: Zoladex; Patients received 3.6 mg subcutaneous Zoladex; Drug: LY01005; Patients received 3.6 mg intramuscular LY01005

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preference	Patient preference (assessed by a single question) between Zoladex and LY01005 after completion of the second period of treatment.	Assessed up 16 weeks after randomization

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: GOMIMP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No