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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03120832
Eligibility Criteria:
Inclusion Criteria:
1. Signed and dated written Ethics Committee approved informed consent
2. Men aged 21 to 85 years with a histologic diagnosis of prostate cancer with a biochemical relapse following definitive local therapy (RP or radiation therapy)
3. Patients are not eligible or are unwilling to receive additional definitive therapy following relapse (either RP or radiation therapy)
4. No prior cytotoxic chemotherapy for the current cancer
5. Normal electrocardiogram (ECG) or ECG with no clinically significant findings as determined by the Principal Investigator
6. Presence of biochemically relapsed prostate cancer defined as either: 1) PSA \> 2 ng/mL 1 year following initial definitive treatment for prostate cancer: or, 2) PSA doubling time (greater than 0.2 ng/mL) \< 12 months; or, 3) PSA velocity \> 2 ng/mL/year at any time following radical prostatectomy or radiation therapy.
7. Positive expression of HAAH in either archived tumor tissue (if available) or fresh serum
8. No clinical or radiologic evidence of distant metastatic disease as measured by pelvic MRI or CT scan in addition to bone scan. These studies will need to be performed within 56 (+ 7 days) days prior to the start of the study.
9. No history of immunosuppressive disease
10. No evidence of active autoimmune disease. Active autoimmune disease is defined as any disease process that has specifically needed administration of immune suppressive and or cytoreductive therapy currently or within the last 1 year.
11. Able and willing to comply with all study procedures
Exclusion criteria:
1. PSA doubling time of \< 3 months
2. Participation in a clinical trial within 30 days prior to enrollment
3. Prior major surgery or radiation therapy within 4 weeks of enrollment
4. Any illness or condition that in the opinion of the Investigator may affect the safety of the patient or the evaluation of any study endpoint
5. Screening blood counts of the following:
Hematopoietic:
Absolute neutrophil count \< 1500/μL, Platelets \< 100,000/μL, Hemoglobin \< 9 g/dL;
Liver/Metabolic:
Alanine aminotransferase (ALT) and aspartate transaminase (AST) \> 2.5 × ULN range, Total bilirubin \> 2 × ULN, Albumin \< 2.8 g/dL;
Renal:
Creatinine clearance \< 50 mL/min as predicted by the Cockcroft-Gault formula
6. Subjects whose partners are WOCBP must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug
7. Current or anticipated concomitant immunosuppressive therapy (excluding nonsystemic inhaled, topical skin and/or eye drop-containing corticosteroids)
8. Any concurrent condition requiring the continued use of systemic steroids (see above) or the use of immunosuppressive agents including methotrexate. All other systemic corticosteroids must be discontinued at least 4 weeks prior to first study treatment
9. Receipt of any blood product within 1 month of enrollment
10. Receipt of any vaccine within 4 weeks of enrollment
11. Active drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements
12. Been imprisoned or compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infectious disease) illness
13. Patients who have a history of coagulopathies, thrombosis or who are receiving active anticoagulation for any condition, such as but not limited to, artificial heart valves, atrial fibrillation, etc.
14. Any other conditions judged by the Investigator that would limit the evaluation of a subject
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT03120832
Study Brief:
Protocol Section:
NCT03120832