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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT03315260
Eligibility Criteria:
Inclusion Criteria:
* Age ≥20 years old (age of maturity in Japan)
* Male, diagnosed with CRPC
* With ≥2 bone metastases and no visceral metastasis based on the most recent imaging procedure
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1, not in end-stage palliative care
* Designated by examining physician to undergo Ra-223 treatment either in the 1st, 2nd, or 3rd line of CRPC therapy
* Has provided written, informed consent (in Japanese)
* Has ≥6 months life expectancy
Exclusion Criteria:
* Participation in an investigational program with interventions outside of routine clinical practice
* Currently receiving any chemotherapy for CRPC or any new hormone therapy (enzalutamide, abiraterone acetate) at enrolment
* Where any of the below conditions apply:
* Started or switched to new androgen deprivation therapy (ADT) (e.g., LHRH agonists and antagonists, anti-androgens, estrogens,) within 4 weeks prior to enrolment or planning to start new treatment prior to 1st Ra-223 injection
* Treatment with anticancer-chemotherapy within previous 4 weeks, or planned before the 1st Ra-223 injection, or failure to recover from adverse events (AEs) (CTCAE Grade \>2) due to anticancer chemotherapy administered more than 4 weeks prior
* Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the previous 24 weeks
* Previous hemi-body external radiotherapy
* Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
* Presence of other maligancy at enrolment
* Otherwise deemed incapable of participating by examining physician
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT03315260
Study Brief:
Protocol Section:
NCT03315260