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

Primary Purpose

Prostate Cancer

Status

Withdrawn

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

Eligibility Criteria

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

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

Sites / Locations

Washington University

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

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.

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.

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.

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.

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.

Secondary Outcome Measures

optimal SUVmax and SUVpeak thresholds on [89]Zr-Df-IAb2M PET/CT for discriminating positive and negative tumor pathology results.

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.

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.

Location and number of positive lesions on [89]Zr-Df-IAb2M PET/CT in subjects with equivocal or negative conventional imaging scans.

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.

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.

Full Information

NCT ID

NCT02424513

First Posted

April 14, 2015

Last Updated

May 29, 2015

Sponsor

ImaginAb, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02424513

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Clinical trial was postponed as a result of restructured business priorities.

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ImaginAb, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (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

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

6 weeks

Title

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.

Time Frame

6 weeks

Title

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.

Time Frame

6 weeks

Title

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.

Time Frame

6 weeks

Title

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.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

optimal SUVmax and SUVpeak thresholds on [89]Zr-Df-IAb2M PET/CT for discriminating positive and negative tumor pathology results.

Time Frame

6 weeks

Title

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.

Time Frame

6 weeks

Title

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.

Time Frame

6 weeks

Title

Location and number of positive lesions on [89]Zr-Df-IAb2M PET/CT in subjects with equivocal or negative conventional imaging scans.

Time Frame

6 weeks

Title

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.

Time Frame

6 weeks

Title

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

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.

Time Frame

12 weeks

Title

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.

Time Frame

12weeks

Title

Number of Participants with Anti-drug antibody (ADA) in serum due to [89]Zr-Df-IAB2M injection as a measure of safety and tolerability.

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Eastham, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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