Clinical Trials Logo
  1. Home
  2. Adenocarcinoma of the Prostate
  3. NCT02048150

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

Adenocarcinoma of the Prostate Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02048150
Study type Interventional
Source City of Hope Medical Center
Contact
Status Completed
Phase Phase 1
Start date March 5, 2015
Completion date February 1, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT02217709 - Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer Phase 2
Completed NCT03077659 - Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer Phase 2
Active, not recruiting NCT03624660 - Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer N/A
Completed NCT01054079 - Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer Phase 2
Terminated NCT00512668 - Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer Phase 1
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Completed NCT00182052 - Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer Phase 3
Active, not recruiting NCT03511196 - Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer Early Phase 1
Active, not recruiting NCT01655836 - High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer Phase 1
Terminated NCT03535675 - Muscadine Plus (MPX) In Men With Prostate Cancer Phase 3
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT02234921 - Pilot Study of DRibble Vaccine for Prostate Cancer Patients Phase 1
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT03686683 - Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer Phase 3
Active, not recruiting NCT03689699 - Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) Phase 1/Phase 2
Recruiting NCT04694924 - Prospective Prostate Cancer and Patient-reported Outcomes Registry
Active, not recruiting NCT04909294 - Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma N/A
Completed NCT02225925 - Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound N/A
Completed NCT01949519 - Docetaxel and Lycopene in Metastatic Prostate Cancer Phase 1
Completed NCT01433913 - Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery Phase 2