Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer

March 17, 2023 updated by: City of Hope Medical Center

Intra-operative Optical Imaging Utilizing Anti-PSMA (Prostate Specific Membrane Antigen) Fluorescent Antibody During Robotic Assisted Laparoscopic Prostatectomy

This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in visualization of the prostate. Attaching a fluorescence, a substance that emits radiation that is visible, to the anti-PMSA antibody and injecting it into the body may help identify the tumor when specialized microscopes are used.

Study Overview

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

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Correlative studies
Other Names:
  • pharmacological studies
Given IV
Other Names:
  • MDX1201
  • MDX1201-A488
Undergo RALP
Undergo IOOI
Other Names:
  • diffuse optical spectroscopy
  • diffuse optical tomography
  • DOI
  • near infrared optical tomography
Correlative studies
Ancillary studies

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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ali Zhumkhawala, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2015

Primary Completion (Actual)

May 10, 2018

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

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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