To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385847
• Other study ID #: GOMIMP
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Xuegang Wang, doctor
• Phone: 15960263909
• Email: stefwxg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoladex
Patients received 3.6 mg subcutaneous Zoladex
• LY01005
Patients received 3.6 mg intramuscular LY01005

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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