Last updated: March 21, 2022
Sponsor: Zodiac Produtos Farmaceuticos S.A.
Overall Status: Completed
Phase
4
Condition
Prostate Cancer, Early, Recurrent
Prostate Disorders
Prostate Cancer
Treatment
N/AClinical Study ID
NCT05304169
1500100
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 formulationfor at least 3 months and for a maximum of 18 months OR;
- Having an indication to start treatment with quarterly goserelin acetate depotformulation.
- Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2;
- Patient with appropriate castration level, defined by a serum testosterone level ≤50ng/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 (alanineaminotransferase) ≤40 U/L, alkaline phosphatase <130 U/L, gamma-GT (glutamyltransferase) <100 U/L;
- Appropriate kidney function in the screening period of the study: serum urea withinnormal 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
Exclusion Criteria:
- Patients who did not have or do not have an indication for treatment with goserelinacetate;
- 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 diastolicpressure ≥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 thepatient's participation in the study;
- Having participated in another clinical study within less than 12 months.
Study Design
Total Participants: 48
Study Start date:
November 14, 2017
Estimated Completion Date:
June 15, 2020
Study Description
Connect with a study center
CPMEC - Hospital Nossa Senhora da Conceição
Porto Alegre, RS
BrazilSite Not Available
HCB - Hospital do Câncer de Barretos
Barretos, SP
BrazilSite Not Available
Hospital Amaral Carvalho
Jaú, SP
BrazilSite Not Available
CIP - Centro Integrado de Pesquisa
São José do Rio Preto, SP
BrazilSite Not Available
ICESP - Instituto do Câncer do Estado de São Paulo
São Paulo, SP
BrazilSite Not Available
IAMSPE - Instituto de Assistência Médica ao Servidor Público Estadual de S. Paulo
São Paulo,
BrazilSite Not Available
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