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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02048150
Collaborator
National Cancer Institute (NCI) (NIH)
20
Enrollment
1
Location
1
Arm
93.9
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: anti-PSMA monoclonal antibody MDX1201-A488
  • Procedure: robot-assisted laparoscopic surgery
  • Other: diffuse optical imaging
  • Other: pharmacological study
  • Other: Laboratory Biomarker
  • Other: Questionnaire
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Intra-operative Optical Imaging Utilizing Anti-PSMA (Prostate Specific Membrane Antigen) Fluorescent Antibody During Robotic Assisted Laparoscopic Prostatectomy
Actual Study Start Date :
Mar 5, 2015
Actual Primary Completion Date :
May 10, 2018
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/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.

Biological: anti-PSMA monoclonal antibody MDX1201-A488
Given IV
Other Names:
  • MDX1201
  • MDX1201-A488
  • Procedure: robot-assisted laparoscopic surgery
    Undergo RALP

    Other: diffuse optical imaging
    Undergo IOOI
    Other Names:
  • diffuse optical spectroscopy
  • diffuse optical tomography
  • DOI
  • near infrared optical tomography
  • Other: pharmacological study
    Correlative studies
    Other Names:
  • pharmacological studies
  • Other: Laboratory Biomarker
    Correlative studies

    Other: Questionnaire
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Imaging ability of anti-PMSA monoclonal antibody MDX1201-A488 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    36 Years to 74 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1City of Hope Medical CenterDuarteCaliforniaUnited States91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT02048150
    Other Study ID Numbers:
    • 13405
    • NCI-2013-02476
    • 13405
    First Posted:
    Jan 29, 2014
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2021

    Study Results

    No Results Posted as of Mar 18, 2022