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

Primary Purpose

Adenocarcinoma of the Prostate, Stage IIB Prostate Cancer, Stage III Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anti-PSMA monoclonal antibody MDX1201-A488
robot-assisted laparoscopic surgery
diffuse optical imaging
pharmacological study
Laboratory Biomarker
Questionnaire
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenocarcinoma of the Prostate

Eligibility Criteria

36 Years - 74 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (MDX1201-A488, IOOI, RALP)

Arm Description

Patients receive anti-PSMA monoclonal antibody MDX1201-A488 IV over 30 minutes on day 1 and undergo IOOI during RALP on day 3.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2014
Last Updated
March 17, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02048150
Brief Title
Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer
Official Title
Intra-operative Optical Imaging Utilizing Anti-PSMA (Prostate Specific Membrane Antigen) Fluorescent Antibody During Robotic Assisted Laparoscopic Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2015 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (MDX1201-A488, IOOI, RALP)
Arm Type
Experimental
Arm Description
Patients receive anti-PSMA monoclonal antibody MDX1201-A488 IV over 30 minutes on day 1 and undergo IOOI during RALP on day 3.
Intervention Type
Biological
Intervention Name(s)
anti-PSMA monoclonal antibody MDX1201-A488
Other Intervention Name(s)
MDX1201, MDX1201-A488
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
robot-assisted laparoscopic surgery
Intervention Description
Undergo RALP
Intervention Type
Other
Intervention Name(s)
diffuse optical imaging
Other Intervention Name(s)
diffuse optical spectroscopy, diffuse optical tomography, DOI, near infrared optical tomography
Intervention Description
Undergo IOOI
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Imaging ability of anti-PMSA monoclonal antibody MDX1201-A488
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Zhumkhawala, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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

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