Assessing Patient Preference for Goserelin Microsphere vs. Goserelin Implant in Prostate Cancer

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

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
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06385847 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are male patients over 18 years old with histologically confirmed prostate adenocarcinoma who are suitable for androgen deprivation therapy.

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.

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 performed: While previous studies have confirmed the efficacy and safety of both treatment options, this specific focus on patient preference is novel.

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

Where this trial is running

Xiamen, Fujian

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Xuegang Wang, doctor

Conditions Prostate Cancer