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

NCT06385847 | Recruiting Phase 2 DMC

• 1 other identifier: GOMIMP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Zo-LY

OTHER

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; Drug: LY01005

LY-Zo

OTHER

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; Drug: LY01005

Interventions

Zoladex DRUG

Patients received 3.6 mg subcutaneous Zoladex

LY-Zo; Zo-LY

LY01005 DRUG

Patients received 3.6 mg intramuscular LY01005

LY-Zo; Zo-LY

Eligibility Criteria

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

You may qualify if:

• Male patients older than 18 years
• Histologically confirmed prostate adenocarcinoma
• Suitable for ADT treatment
• ECOG≤2
• Prior treatment without GnRH agonists
• Expected survival \>1 year
• Good compliance
• 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

You may not qualify if:

• Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for \< 6 months and discontinued for more than 6 months were allowed
• Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions
• 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
• Any medical conditions that the investigators believe make the patient ineligible to participate in the study

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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)

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

Central Study Contacts

Xuegang Wang, doctor

CONTACT

15960263909; stefwxg@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Model Details: Prospective, randomized, open-label, cross-over phase II trial

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (1)