Clinical trial NCT02424513: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: ImaginAb, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-23
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Histological diagnosis of prostate adenocarcinoma.
2. 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.
3. 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.
4. Age ≥ 18 years.
5. Ability to understand and willingness to sign IRB approved consent form
6. For men of child-producing potential, the use of effective contraceptive methods during the study.

Exclusion Criteria:

1. 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.
2. Unwillingness or inability to comply with procedures required in this protocol.
3. Other cancers that might potentially interfere with the reading and interpretation of \[89\]Zr-Df-IAB2M PET/CT scans.
4. Patients who are currently receiving any other investigational agent.
5. Patients who have had or are currently receiving androgen deprivation therapy

Primary outcomes:
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
Secondary outcomes:
measure: optimal SUVmax and SUVpeak thresholds on [89]Zr-Df-IAb2M PET/CT for discriminating positive and negative tumor pathology results.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: Location and number of positive lesions on [89]Zr-Df-IAb2M PET/CT in subjects with equivocal or negative conventional imaging scans.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
Other outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12weeks
measure: Number of Participants with Anti-drug antibody (ADA) in serum due to [89]Zr-Df-IAB2M injection as a measure of safety and tolerability.
timeFrame: 12 weeks
Locations:
city: St Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Eastham, MD
role: PRINCIPAL_INVESTIGATOR
References: