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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT03137758
Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed diagnosis of metastatic CRPC
* standard of care androgen deprivation treatment
* castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
* progressive disease while receiving androgen deprivation therapy
* previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
* adequate hematologic, renal and hepatic function
* KPS of ≥ 70 or ECOG of 0 to 1
Exclusion Criteria:
* pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
* use of opiate analgesics for prostate cancer pain within 4 week of treatment start
* more than one sequential second generation AR-directed therapy
* received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
* history of bleeding disorder
* history of seizure disorder
* concomitant use of therapeutic anticoagulation
* history of or current cardiac issues
* received external beam radiation therapy within 4 weeks
* CTCAE Grade \> 2 neuropathy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03137758
Study Brief:
Protocol Section:
NCT03137758