Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05304169
Eligibility 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05304169
Study Brief:
Protocol Section:
NCT05304169