- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02048150
Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer
Intra-operative Optical Imaging Utilizing Anti-PSMA (Prostate Specific Membrane Antigen) Fluorescent Antibody During Robotic Assisted Laparoscopic Prostatectomy
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES: I. Determine the preferred imaging dose (if any), based on image quality and correlation with pathological findings, of intravenously administered MDX1201-A488 in a dose-escalating study (doses of 5 and 15 mg) in patients with moderate to high-risk prostate cancer prior to undergoing robotic assisted laparoscopic prostatectomy (RALP), subject to predetermined safety stopping rules.
SECONDARY OBJECTIVES: I. Correlate intra-operative optical imaging (IOOI) findings with pre-operative magnetic resonance imaging (MRI) findings and clinical staging.
OUTLINE: This is a dose-escalation study. Patients receive anti-PSMA monoclonal antibody MDX1201-A488 intravenously (IV) over 30 minutes on day 1 and undergo IOOI during RALP on day 5.
After completion of study treatment, patients are followed up at 4-7 weeks, 3 months, 6 months, 9 months, and 1 year.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate; patients with small cell, neuroendocrine, and transitional cell carcinomas are not eligible
- Patients being considered for RALP and pelvic lymphadenectomy with life expectancy greater than 10 years as determined by treating physician
Patients with moderate to high-risk disease as defined by D' Amico risk stratification and having at least one of the following:
- Prostate-specific antigen (PSA) level > 10 ng/ml
- Gleason score >= 7
- Clinical stage >= T2c
- Any performance status on the Eastern Cooperative Oncology Group (ECOG)
- Men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
- Bone scan without evidence of skeletal metastases
- Skeletal x-ray film or MRI confirmation of absent skeletal metastases if bone scan findings are equivocal
- 3Tesla (T) multiparametric MRI of the prostate performed at City of Hope (COH) within 6 week time period prior to surgery; MRI without evidence of bladder neck involvement, rectal wall involvement, or pelvic lymphadenopathy with no nodes > 1 cm
- White blood cell (WBC) within normal limits
- Hemoglobin (hgb) > 10 G/dL
- Platelet count (PLT) > 100 K/uL
- Creatinine clearance within normal limits
- Serum glutamic oxaloacetic transaminase (SGOT) < 1.5 x upper limit of normal (ULN)
- Serum glutamate pyruvate transaminase (SGPT) < 1.5 x ULN
- Bilirubin < 1.5 x ULN
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients should not have any uncontrolled illness including ongoing or active infection
- Prior treatment of prostate cancer including brachytherapy, radiation therapy, cryosurgery, high-intensity focused ultrasound (HIFU), or vaccine therapy
- Prior pelvic surgery or radiation
- Urinary incontinence requiring condom catheter use or >= 1 pad/day
- Prior anti-incontinence surgery
- Use of neoadjuvant hormonal manipulation
- History of active co-existing non-prostatic malignancies except basal cell skin cancer or squamous cell skin cancer
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (MDX1201-A488, IOOI, RALP)
Patients receive anti-PSMA monoclonal antibody MDX1201-A488 IV over 30 minutes on day 1 and undergo IOOI during RALP on day 3.
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Correlative studies
Other Names:
Given IV
Other Names:
Undergo RALP
Undergo IOOI
Other Names:
Correlative studies
Ancillary studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging ability of anti-PMSA monoclonal antibody MDX1201-A488
Time Frame: Up to 1 year
|
The main fluorescence metric will be the minimum fluorescence observed in 10 sampled high power fields from a single representative cancerous section taken per patient.
Other metrics will be the mean fluorescence observed in the 10 sampled high power fields, and the median fluorescence observed.
The minimum fluorescence is chosen based on the concept that the primary focus is on observing the fluorescence, and areas of peak fluorescence greatly influence the mean, and also have some influence on the median, yet may be of limited relevance.
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Up to 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ali Zhumkhawala, MD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13405 (City of Hope Medical Center)
- NCI-2013-02476 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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