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Clinical trial was postponed as a result of restructured business priorities.
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This is a prospective, multicenter, open-label, non-randomized study evaluating the ability of [89]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology.
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with [89]Zr. [89Zr]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions.
This is a phase 2, prospective, multi-center, open-label, non-randomized study evaluating the ability of [89]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology in patients with biopsy-proven prostate cancer thought to be candidates for radical prostatectomy and pelvic lymph node dissection who are at high-risk for pelvic lymph node metastasis. These patients may have identified lymphadenopathy on conventional imaging but are considered eligible if still judged to be candidates for radical prostatectomy and lymph node dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [89Zr]Df-IAB2M | Experimental | A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [89Zr]Df-IAB2M | Radiation | A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue. | 6 weeks | |
| Specificity of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue. | 6 weeks | |
| Positive Predicted Value of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue. | 6 weeks | |
| Negative Predicted Value of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue. | 6 weeks | |
| Accuracy of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| optimal SUVmax and SUVpeak thresholds on [89]Zr-Df-IAb2M PET/CT for discriminating positive and negative tumor pathology results. | 6 weeks | |
| Optimal SUV ratio thresholds on [89]Zr-Df-IAb2M PET/CT for discriminating positive and negative tumor pathology results, where the ratio is calculated using an appropriate reference tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events or Serious Adverse Events attributable to [89]Zr-Df-IAB2M administration according to MedDRA/CTCAE v. 4.03 as a measure of safety and tolerability. | 12 weeks | |
| Number of Participants with clinically significant changes in physical examination findings, vital signs, and blood chemistry from screening to follow-up analysis as a measure of safety and tolerability. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Eastham, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000630605 | 89Zr-Df-IAB2M |
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| 6 weeks |
| Sensitivity and specificity of [89]Zr-Df-IAb2M PET/CT compared to the sensitivity and specificity of conventional imaging for the detection of lesions as confirmed by pathology. | 6 weeks |
| Location and number of positive lesions on [89]Zr-Df-IAb2M PET/CT in subjects with equivocal or negative conventional imaging scans. | 6 weeks |
| Sensitivity and specificity of [89]Zr-Df-IAb2M PET/CT to identify patients who are positive or negative for metastatic disease as identified by pathology. | 6 weeks |
| Sensitivity and specificity of IAB2M [89]Zr-Df-IAb2M PET/CT to identify disease as confirmed by pathology individually in each of the resected areas including: left and right external iliac, obturator and internal iliac nodes. | 6 weeks |
| 12weeks |
| Number of Participants with Anti-drug antibody (ADA) in serum due to [89]Zr-Df-IAB2M injection as a measure of safety and tolerability. | 12 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |