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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 36 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-03-05
• Primary completion: 2018-05-10
• Completion: 2023-02-01
• First posted: 2014-01-29
• Last updated: 2023-03-21

Locations

1 site across 1 country: United States