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

NCT ID: NCT02048150

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-05
• Study Completion Date: 2023-02-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

anti-PSMA monoclonal antibody MDX1201-A488

Intervention Type: BIOLOGICAL

Given IV

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo RALP

diffuse optical imaging

Intervention Type: OTHER

Undergo IOOI

pharmacological study

Intervention Type: OTHER

Correlative studies

Laboratory Biomarker

Intervention Type: OTHER

Correlative studies

Questionnaire

Intervention Type: OTHER

Ancillary studies

Interventions

anti-PSMA monoclonal antibody MDX1201-A488

Given IV

Intervention Type: BIOLOGICAL

robot-assisted laparoscopic surgery

Undergo RALP

Intervention Type: PROCEDURE

diffuse optical imaging

Undergo IOOI

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Laboratory Biomarker

Correlative studies

Intervention Type: OTHER

Questionnaire

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

MDX1201; MDX1201-A488; diffuse optical spectroscopy; diffuse optical tomography; DOI; near infrared optical tomography; pharmacological studies

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

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Zhumkhawala, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2013-02476

Identifier Type: REGISTRY

Identifier Source: secondary_id

13405

Identifier Type: OTHER

Identifier Source: secondary_id

13405

Identifier Type: -

Identifier Source: org_study_id