Assessing Patient Preference for Goserelin Microsphere vs. Goserelin Implant in Prostate Cancer
Official title: Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
Run by The First Affiliated Hospital of Xiamen University · NCT06385847 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to find out which form of goserelin treatment—microsphere or implant—men with prostate cancer prefer and feel more satisfied with.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06385847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are male patients over 18 years old with histologically confirmed prostate adenocarcinoma who are suitable for androgen deprivation therapy.
✕Probably not a fit
Patients with prior treatment using goserelin or other GnRH agonists, or those with hormone-resistant prostate cancer, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to explore patient preferences between two forms of androgen deprivation therapy for prostate cancer: goserelin microsphere and goserelin implant. It is a prospective, randomized, cross-over trial involving male patients with histologically confirmed prostate adenocarcinoma who are suitable for treatment. The study will compare the administration methods and patient satisfaction with each treatment option, as previous studies have confirmed their similar efficacy and safety. The trial will help determine which method patients prefer, potentially influencing future treatment choices.
Why it matters
Potential benefit: If successful, this study could provide insights into patient preferences that may enhance treatment adherence and satisfaction.
How similar studies have gone: While previous studies have confirmed the efficacy and safety of both treatment options, this specific focus on patient preference is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China Recruiting
Study contacts
- Study coordinator: Xuegang Wang, doctor
- Email: stefwxg@163.com
- Phone: 15960263909
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.