Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.

• Status: Completed
• Trial end date: 2020-06-15
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zodiac Produtos Farmaceuticos S.A.
• Treatments: Leuprolide

Criteria

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.