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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07450157
Eligibility Criteria:
Phase I inclusion criteria:
1. Patients with ≥1 claim in the open-source medical claims data with a Healthcare Common Procedure Coding System (HCPCS) code of A9607 or ≥1 claim in the open-source medical or pharmacy claims data with a National Drug Code (NDC) code for 177Lu-PSMA-617 during the patient selection window. The date of the first such claim is the index date.
2. For patients identified via NDC code, ≥1 claim with one of the following procedure codes on the same date as the 177Lu-PSMA-617 NDC claim: HCPCS - A9699, J3590; CPT 79191; or ≥1 claim with HCPCS code A9595 or A9597 occurring within 14 days before or after the index date.
3. At least 18 years of age at index date.
4. Patients with ≥2 medical claims ≥180 days prior to the index date.
For the treatment response analysis, the following additional criteria were applied:
5. Patients with linkage to lab data.
6. Patients with ≥1 PSA result available on or within 6 months prior to the index date. The PSA result closest to the index date was defined as the baseline PSA level.
7. Patients with ≥1 PSA result available after the index date.
Phase II inclusion criteria:
1. ≥2 medical claims (≥30 days apart) with a diagnosis of prostate cancer observed during the patient selection period.
2. ≥1 medical claim with a diagnosis code for metastatic disease occurring on or after the first observed prostate cancer diagnosis. The date of the first such claim was defined as the date of metastasis.
3. Evidence of castration resistance observed during the study period. The date of mCRPC diagnosis was defined as the latest of the date of metastasis and the date of castration resistance and must have occurred during the index window.
4. ≥12 months of continuous data availability prior to the mCRPC diagnosis date.
5. ≥1 claim for 177Lu-PSMA-617 after mCRPC diagnosis and continuous data availability between diagnosis and the date of 177Lu-PSMA-617 initiation.
Exclusion criteria
1\. Standard data cleaning processes were applied to remove patients with data quality issues. Specific data quality issues included missing or invalid age or sex.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07450157
Study Brief:
Protocol Section:
NCT07450157