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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT01543659
Eligibility Criteria:
Inclusion Criteria:
Metastatic Prostate Cancer Patients:
* Adult male ≥ 18 years of age
* Patients with histologically confirmed prostate cancer at MSKCC
* Progressive disease manifest by either:
* Imaging modalities:
* Bone Scan: New osseous lesions on bone scan and/or
* MRI or CT: An increase in measurable soft tissue disease or the appearance of new sites of disease.
OR
* Biochemical progression:
At least 3 rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements obtained 2 or more weeks apart. The increase over the range of values should be at least 25%.
* Visible lesions by CT, bone scan, or MRI that are consistent with disease
* Performance status of 60 or higher (Karnofsky scale) (Appendix B)
* Ability to understand and willingness to sign a written informed consent document
Rising PSA Prostate Cancer Patients:
* Adult male ≥18 years of age
* Patients with histologically confirmed prostate cancer at MSKCC
* Undergone radical prostatectomy
* Detectable PSA (\>0.05 ng/mL) that rises on subsequent evaluation
* Radiographic evaluation involving bone imaging and cross sectional imaging of at least the pelvis that is negative or equivocal for metastatic disease
* Performance status of 60 or higher (Karnofsky scale) (Appendix B)
* Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
* Patients meeting any of the following criteria will not be eligible for study entry (Metastatic and Rising PSA cohorts):
* Previous anaphylactic reaction to either J591 or FDG
* Hepatic laboratory values
* Bilirubin \> 1.5 x ULN (institutional upper limits of normal) Exception: patient's with a history of Gilbert's disease
* AST/ALT \> 2.5 x ULN
* Albumin \< 2 g/dL
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01543659
Study Brief:
Protocol Section:
NCT01543659