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

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how patients with prostate cancer prefer two different forms of a medication called goserelin: one is a microsphere version (Zoladex®) and the other is an implant version (LY01005). The trial is designed for men aged 65 to 74 who have been diagnosed with prostate cancer and are suitable for hormone therapy. To join the study, participants need to be at least 18 years old, have a confirmed diagnosis of prostate cancer, and meet certain health criteria. Those who have previously received certain types of treatments or have specific health issues may not be eligible.

If you decide to participate, you will be randomly assigned to receive one of the two forms of goserelin, and then switch to the other form later on. This way, the study can find out which option patients prefer. Throughout the trial, participants will be monitored for their health and any side effects from the treatments. It's important to know that this trial is currently recruiting participants, so if you're interested and meet the eligibility criteria, you could play a key role in helping researchers understand which treatment option is better for patients like you.

Gender

MALE

Eligibility criteria

• 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