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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT07285694
Eligibility Criteria:
Key Inclusion Criteria:
1. At least 18 years of age at time of signing informed consent form.
2. Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
• Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria.
3. Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.
• PSMA+ by PSMA PET.
* Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng/mL) per PCWG3 criteria.
4. Adequate organ functions.
Key Exclusion Criteria:
1. Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.
2. Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
3. Unwillingness to participate in an extended safety monitoring period.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07285694
Study Brief:
Protocol Section:
NCT07285694