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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04117594
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent
2. Age ≥18 years
3. Patients with APC with predominantly bone disease confirmed by bone scan (within 6 weeks) or CT (within 6 weeks), of starting treatment (Cycle 1 Day 1). Patients with local recurrence and bone metastases with an associated soft tissue component, will be allowed into the trial. Pelvic lymphadenopathy \<1.5cm in short axis is not an exclusion.
4. Systemic therapy indicated for disease progression, as clinically indicated.
Exclusion Criteria:
1. Patient is claustrophobic.
2. Contraindications to MRI examination (e.g. cardiac pacemakers, cochlear implants).
3. Measurable soft tissue or lymph node metastases or any metastatic disease outside the bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease \<1.5cm in short axis). Bone metastases with associated soft tissue components will also not be an exclusion.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04117594
Study Brief:
Protocol Section:
NCT04117594