Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.
Lead Sponsor:
Zodiac Produtos Farmaceuticos S.A.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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 aceta...
Detailed Description
When systemic treatment is indicated, androgen deprivation therapy is the standard treatment for patients with prostate cancer. This condition occurs when the patient is diagnosed with metastatic dise...
Eligibility Criteria
Inclusion
- Patient able to understand the process of the informed consent form (ICF);
- Male aged ≥18 years old;
- Having a histologically confirmed diagnosis of prostate adenocarcinoma;
- Having an indication of androgen deprivation treatment:
- Being on treatment with monthly or quarterly goserelin acetate depot formulation for at least 3 months and for a maximum of 18 months OR;
- Having an indication to start treatment with quarterly goserelin acetate depot formulation.
- Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2;
- Patient with appropriate castration level, defined by a serum testosterone level ≤50 ng/dL (≤1.73 nmol/L) demonstrated before V1.
- Appropriate hematologic function in the screening period: neutrophil count \>1,500/μL, platelets \>100,000/μL, hemoglobin \>10 g/dL;
- 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;
- 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
- Patients who did not have or do not have an indication for treatment with goserelin acetate;
- Patients with goserelin treatment for over 18 months;
- Patients who have received previous chemotherapy;
- Patient unable to follow the foreseen study visit schedule;
- Suspected or proven brain metastasis or active leptomeningeal disease;
- Uncontrolled arterial hypertension defined as systolic pressure ≥160 mmHg or diastolic pressure ≥95 mmHg;
- Long-term use of estrogen therapy or peripheral blockade;
- Another concomitant neoplasm;
- Any medical condition which, at the investigator's discretion, offers risk to the patient's participation in the study;
- Having participated in another clinical study within less than 12 months.
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05304169
Start Date
November 14 2017
End Date
June 15 2020
Last Update
March 31 2022
Active Locations (6)
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1
CPMEC - Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
2
HCB - Hospital do Câncer de Barretos
Barretos, São Paulo, Brazil
3
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
4
CIP - Centro Integrado de Pesquisa
São José do Rio Preto, São Paulo, Brazil