Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Genentech, Inc.
Age
21–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
To be included in this study, patients should be eligible for enrollment into protocol 11-016 (therapy with the DSTP3086S ADC) or meet all of the following criteria:
Patients meeting the criteria for enrollment on research protocol 11-016 to receive DSTP3086S ADC (therapeutic ADC based on MSTP2109A) will be the preferred patients for this study. Patients that are to receive DSTP3086S will not be injected with DSTP2086S until imaging with 89Zr-DFOMSTP2109A is finished, approximately 1 week.
Adult male \> 21years of age
Visible lesions by either CT, bone scan or MRI consistent with metastatic disease
Metastatic progressive disease
Imaging modalities:
Bone scan: new osseous lesion and/or MRI or CT: An increase in measurable soft tissue disease or the appearance of new sites of disease.
Or
PSA changes over range of value 26%
Patients with histologically confirmed prostate cancer at MSKCC
STEAP1 antigen positive tissue known from prior IHC testing or if STEAP1 status is not known archival sample will be sent to Genentech for IHC. Samples need to be positive, when feasible metastatic lesions will be tested preferentially rather than the primary.
Performance status of 60 or higher (Karnofsky scale) (Appendix A)
Ability to understand and willingness to sign a written informed consent document
PSA levels to be taken within 2 weeks of antibody administration.
You may not be if
Previous anaphylactic reaction to human, humanized or chimeric antibody
Hematologic
Platelets \<75K/mcL
ANC \<1.0 K/mcL
Hepatic laboratory values
AST/ALT \>2.5 x ULN
Renal laboratory values
Bilirubin \>1.5 x ULN (institutional upper limits of normal)
eGFR \< 30mL/min/1.73m2
Patients with history of hypersensitivity reaction to any component of 89Zr-DFOMSTP2109A, including DFO