Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
The purpose of this study is to compare the diagnostic performance of \[89Zr\]-Df-IAB2M PET/CT with that of \[111In\]-capromab pendetide as an immuno PET tracer in the detection of prostate cancer pre-prostatectomy as confirmed by pathology. Individuals participating in this study will have a \[111In\]-capromab pendetide scan, as well as a PET scan following the injection of \[89Zr\]-Df-IAB2M.
Key facts
- Study ID
- NCT02349022
- Run by
- ImaginAb, Inc.
- People needed
- 19
- Starts
- 2015-01-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2020-02-13
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Patients must meet ALL criteria listed below for entry:
- Age ≥ 18 years
- Signed, written IRB-approved informed consent
- Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x-ray, CT scan or MRI) who are at high-risk for pelvic lymph node metastases.
- High Risk defined as:
- Gleason score ≥ 8 or
- Gleason 4+3 with a PSA > 10 or
- PSA > 20 ng/mL or
- T3a
- Patients scheduled for a [111In]-capromab pendetide scan or had a recent [111In]-capromab pendetide scan within 28 days of screening visit or would be willing to undergo a [111In]-capromab pendetide scan
- Karnofsky Performance status of ≥ 60
- Life expectancy of at least 6 months
- Patients with any previous history of another malignancy (other than in-situ cancer, basal or squamous cell skin cancer) must be disease free for a period of three years.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal or <3 x ULN for patients with Gilbert's disease
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed)
- Acceptable renal function:
- Serum creatinine within normal limits, OR
- calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Acceptable hematologic status:
- Granulocyte ≥ 1500 cells/mm3
- Platelet count ≥ 150,000 (plt/mm3)
- Hemoglobin ≥ 9 g/dL
- For men of child-producing potential, the use of effective contraceptive methods during the study
You may not qualify if…
- Patients will be excluded from entry if ANY of the criteria listed below are met:
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months
- Unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy for prostate cancer.
- Unwillingness or inability to comply with procedures required in this protocol
- Known infection with HIV, hepatitis B, or hepatitis C
- Serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Previous [111In]-capromab pendetide image test
Where it is running
- Arizona Urology Specialists — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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