Clinical trial · Interventional
Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy
A Phase 2 Study - Comparison Of Positron Emission Tomography (PET/CT) With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [89Zr]Df-IAB2M | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [89Zr]Df-IAB2M
- description
- A single intravenous infusion of 2.5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg.
- interventionNames
- Radiation: [89Zr]Df-IAB2M
Primary outcomes (1)
- measure
- Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology
- timeFrame
- 6 weeks
Secondary outcomes (4)
- measure
- Assess the safety of a single dose of [89Zr]-Df-IAB2M
- timeFrame
- Day 1 through Day 13
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 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
References
Publications (0)
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