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

NCT02048150 | Completed Phase 1 DMC

• 2 other identifiers: 13405NCI-2013-02476
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Study Arms (1)

Diagnostic (MDX1201-A488, IOOI, RALP)

EXPERIMENTAL

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

Biological: anti-PSMA monoclonal antibody MDX1201-A488; Procedure: robot-assisted laparoscopic surgery; Other: diffuse optical imaging; Other: pharmacological study; Other: Laboratory Biomarker; Other: Questionnaire

Interventions

anti-PSMA monoclonal antibody MDX1201-A488 BIOLOGICAL

Given IV

Also known as: MDX1201, MDX1201-A488

Diagnostic (MDX1201-A488, IOOI, RALP)

robot-assisted laparoscopic surgery PROCEDURE

Undergo RALP

Diagnostic (MDX1201-A488, IOOI, RALP)

diffuse optical imaging OTHER

Undergo IOOI

Also known as: diffuse optical spectroscopy, diffuse optical tomography, DOI, near infrared optical tomography

Diagnostic (MDX1201-A488, IOOI, RALP)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Diagnostic (MDX1201-A488, IOOI, RALP)

Laboratory Biomarker OTHER

Correlative studies

Diagnostic (MDX1201-A488, IOOI, RALP)

Questionnaire OTHER

Ancillary studies

Diagnostic (MDX1201-A488, IOOI, RALP)

Eligibility Criteria

• Age: 36 Years - 74 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Tesla (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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ali Zhumkhawala, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 29, 2014
• Study Start: March 5, 2015
• Primary Completion: May 10, 2018
• Study Completion: February 1, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

US (1)