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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02151760
Eligibility Criteria:
Inclusion Criteria:
* Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:
1. Greater than or equal to 18 years of age
2. Histological confirmation of prostate cancer
3. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET
4. PSA ≥ 1.0 ng/mL
5. Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
6. Platelet count \> 50,000/mm3
7. Neutrophil count \> 1,000/mm3
8. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
9. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Exclusion Criteria:
* Patients will be excluded from enrollment if any of the following apply:
1. Karnovsky performance status of \< 60
2. Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
3. Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
4. Administered a radioisotope within 5 physical half-lives prior to study enrollment
5. Serum creatinine \> 3 times the upper limit of normal
6. Total bilirubin \> 3 times the upper limit of normal
7. Liver Transaminases \> 5times the upper limit of normal
8. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
9. Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).
10. Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02151760
Study Brief:
Protocol Section:
NCT02151760