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

NCT02048150 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-03-21

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma of the Prostate
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer

Interventions

BIOLOGICAL

anti-PSMA monoclonal antibody MDX1201-A488

Given IV

PROCEDURE

robot-assisted laparoscopic surgery

Undergo RALP

OTHER

diffuse optical imaging

Undergo IOOI

OTHER

pharmacological study

Correlative studies

OTHER

Laboratory Biomarker

Correlative studies

OTHER

Questionnaire

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Ali Zhumkhawala, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
36 Years
Max Age
74 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-05
Primary Completion
2018-05-10
Completion
2023-02-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02048150 on ClinicalTrials.gov