A Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase 2 Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: [89Zr]Df-IAB2M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of prostate adenocarcinoma. Patients considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients may or may not have identified nodal metastasis on conventional imaging but would still be candidates for radical prostatectomy and pelvic lymph node dissection. Patients, who are at high-risk for pelvic lymph node metastasis as defined by a lymph node involvement risk of greater than or equal to 20% using the Briganti nomogram. Age ≥ 18 years. Ability to understand and willingness to sign IRB approved consent form For men of child-producing potential, the use of effective contraceptive methods during the study. Exclusion Criteria: Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, [89]Zr-Df-IAB2M PET/CT and the surgical resection or biopsy procedures used for the study evaluation. Unwillingness or inability to comply with procedures required in this protocol. Other cancers that might potentially interfere with the reading and interpretation of [89]Zr-Df-IAB2M PET/CT scans. Patients who are currently receiving any other investigational agent. Patients who have had or are currently receiving androgen deprivation therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [89Zr]Df-IAB2M<br>A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg. | Radiation: [89Zr]Df-IAB2M<br>* A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |