Back to results

Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[89Zr]Df-IAB2M

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring [89Zr]Df-IAB2M, Prostate cancer, PET scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arizona Urology Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[89Zr]Df-IAB2M

Arm Description

A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg.

Outcomes

Primary Outcome Measures

Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology

Secondary Outcome Measures

Assess the safety of a single dose of [89Zr]-Df-IAB2M

Histopathologic correlation of PSMA expression and prostate cancer from surgical or biopsy specimens with uptake of [89Zr]-Df-IAB2M on PET/CT

Compare the concordant and discordant rate for positive/negative areas of uptake between [111In]-Capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status

Compare the sensitivity/specificity/PPV/NPV/Accuracy of conventional imaging (CT/MRI/Bone scan) to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status

Full Information

NCT ID

NCT02349022

First Posted

January 23, 2015

Last Updated

February 10, 2020

Sponsor

ImaginAb, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02349022

Brief Title

Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ImaginAb, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with 89Zr. [89Zr]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions. [111In]-capromab pendetide (Prostascint®) is an FDA approved imaging agent targeting the intracellular domain of PSMA. It is anticipated that [89Zr]-Df-IAB2M will outperform Prostascint® because of this targeting difference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

[89Zr]Df-IAB2M, Prostate cancer, PET scan

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

[89Zr]Df-IAB2M

Arm Type

Experimental

Arm Description

A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg.

Intervention Type

Radiation

Intervention Name(s)

[89Zr]Df-IAB2M

Primary Outcome Measure Information:

Title

Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Assess the safety of a single dose of [89Zr]-Df-IAB2M

Time Frame

Day 1 through Day 13

Title

Histopathologic correlation of PSMA expression and prostate cancer from surgical or biopsy specimens with uptake of [89Zr]-Df-IAB2M on PET/CT

Time Frame

Day 1 through Day 13

Title

Time Frame

Day 1 through Day 13

Title

Compare the sensitivity/specificity/PPV/NPV/Accuracy of conventional imaging (CT/MRI/Bone scan) to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status

Time Frame

Day 1 through Day 13

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Arizona Urology Specialists

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85255

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy

We'll reach out to this number within 24 hrs