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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT03162003
Eligibility Criteria:
Inclusion Criteria:
1. Stage 4 mPCa as confirmed by CT/MRI or by bone scan
2. Patient with visceral disease and/or bone lesions (excluding patients who only have nodal disease), who have commenced or are about to commence ADT and whose disease has not shown any evidence of castration resistance (cohort 1) Or Patient with castrate-resistant disease at time of treatment change (cohort 2)
3. Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to recruitment
4. Life expectancy of at least 6 months
5. Ability to give written informed consent obtained before any study-related procedures
6. Age ≥ 18 years and male
Exclusion Criteria:
1. Diagnosis of or treatment for another systemic malignancy within 2 years before study entry.\*
2. Any evidence of residual disease from a previously diagnosed malignancy. \*Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03162003
Study Brief:
Protocol Section:
NCT03162003