Clinical trial · Interventional
Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.
PRospective, Multicenter Study to Evaluate Safety and Efficacy of Switching Treatments of Prostate Cancer Patients, Initially on Use of Monthly or Quarterly Goserelin Acetate (Zoladex®), to Semiannually Leuprorelin Acetate (Eligard®)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy, quality of life and safety of switching from monthly (3.6 mg) or quarterly (10.8 mg) goserelin acetate (Zoladex®) to semiannual leuprorelin acetate 45 mg (Eligard® 45 mg) in prostate cancer patients with adequate hormonal castration level (plasma testosterone levels ≤50 ng/dL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprorelin Acetate (Eligard® 45 mg). | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Leuprorelin Acetate (Eligard® 45 mg)
- description
- Patients received two subcutaneous injections of Eligard® 45 mg (leuprorelin acetate), with the first injection given at baseline (Visit 1) and the second after 168 ± 3 days at Visit 4.
- interventionNames
- Drug: Leuprorelin Acetate (Eligard® 45 mg).
Primary outcomes (1)
- measure
- Baseline testosterone levels (≤50 ng/dL)
- timeFrame
- One year of treatment
- description
- Maintenance of baseline testosterone levels (≤50 ng/dL) after switching from goserelin acetate to leuprorelin acetate 45 mg (Eligard® 45 mg, Zodiac).
Secondary outcomes (6)
- measure
- Efficacy (consecutive PSA > 4 ng/mL)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient able to understand the process of the informed consent form (ICF); 2. Male aged ≥18 years old; 3. Having a histologically confirmed diagnosis of prostate adenocarcinoma; 4. Having an indication of androgen deprivation treatment: 1. Being on treatment with monthly or quarterly goserelin acetate depot formulation for at least 3 months and for a maximum of 18 months OR; 2. Having an indication to start treatment with quarterly goserelin acetate depot formulation. 5. Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2; 6. Patient with appropriate castration level, defined by a serum testosterone level ≤50 ng/dL (≤1.73 nmol/L) demonstrated before V1. 7. Appropriate hematologic function in the screening period: neutrophil count \>1,500/μL, platelets \>100,000/μL, hemoglobin \>10 g/dL; 8. Appropriate liver function in the screening period of the study: total serum bilirubin ≤1.5 x upper normal limit, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) ≤40 U/L, alkaline phosphatase \<130 U/L, gamma-GT (glutamyl transferase) \<100 U/L; 9. Appropriate kidney function in the screening period of the study: serum urea within normal limits for the method used at the institution, serum creatinine between 0.6 and 1.3 mg/dL, creatinine clearance calculated by the Cockroft- Gault formula \> 40 mL/min; Exclusion Criteria: 1. Patients who did not have or do not have an indication for treatment with goserelin acetate; 2. Patients with goserelin treatment for over 18 months; 3. Patients who have received previous chemotherapy; 4. Patient unable to follow the foreseen study visit schedule; 5. Suspected or proven brain metastasis or active leptomeningeal disease; 6. Uncontrolled arterial hypertension defined as systolic pressure ≥160 mmHg or diastolic pressure ≥95 mmHg; 7. Long-term use of estrogen therapy or peripheral blockade; 8. Another concomitant neoplasm; 9. Any medical condition which, at the investigator's discretion, offers risk to the patient's participation in the study; 10. Having participated in another clinical study within less than 12 months.
References
Publications (0)
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