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:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT03085966
Eligibility Criteria:
Inclusion Criteria:
* Males age ≥ 18 years；
* Subjects who understand and sign the consent form for this study；
* Metastatic， castrate resistant, histologically confirmed prostate cancer；
* PSA\> 5ng / ml；
* Serum testosterone ≤ 17nmol / L (50ng / dl)；
* Expected survival time of at least 24 months；
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
* Subjects did not receive chemotherapy, radiation therapy, surgery and other treatment within 4 weeks；
Exclusion Criteria:
* The subject has an allergic history of medicine or food；
* The patient with more serious heart disease, including but not limited to myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia；
* Hb \<9.0 g / 100ml, WBC \<3 ×10\^9/ L, LY \<1.0 x10\^9/ L, platelet \<100,000 / mm3；
* Patients with immune disease or auto-immune disease (such as Multiple sclerosis, systemic lupus erythematosus，rheumatoid arthritis and inflammatory bowel disease, vitiligo )；
* The subject has uncontrolled or hard-to-control diseases of liver, or kidney system；
* Patient with visceral metastases, pathological fractures, spinal cord compression symptoms；
* Severe pain associated with bone metastases (VAS score ≧ 4 points)；
* Patient has received immunotherapy (including but not limited to PD-1 / PDL-1, etc.)；
* patient with irregular hemorrhagic disease；
* Subject is HIV, hepatitis B virus, hepatitis C virus, Treponema pallidum infection；
* Subject has uncontrollable seizures, or because of mental loss of self-knowledge and so on；
* The subject has an history of other malignant tumor；
* The patient had drug abuse, drug abuse, and long history of alcoholism in the 12 years prior to this trial；
* The subject has participated in any other clinical trial in the 3 months prior to this trial；
* The subject has any other unsuitable or adverse condition to be determined by the investigator.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03085966
Study Brief:
Protocol Section:
NCT03085966