Adenocarcinoma of the ProstatePhase 1NCT02048150

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

A Phase 1 study testing anti-PSMA monoclonal antibody MDX1201-A488, robot-assisted laparoscopic surgery and diffuse optical imaging in people with Adenocarcinoma of the Prostate and Stage IIB Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 36 to 74 years, men only
Conditions the study is for: Adenocarcinoma of the Prostate, Stage IIB Prostate Cancer, Stage III Prostate Cancer
What is being tested?: anti-PSMA monoclonal antibody MDX1201-A488, robot-assisted laparoscopic surgery and diffuse optical imaging
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2015to 1 Feb 2023
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 36 to 74 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

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

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.

Read the 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
Being tested: anti-PSMA monoclonal antibody MDX1201-A488, robot-assisted laparoscopic surgery, diffuse optical imaging, pharmacological study, Laboratory Biomarker
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

anti-PSMA monoclonal antibody MDX1201-A488Biological
Also called MDX1201, MDX1201-A488
Given IV
robot-assisted laparoscopic surgeryProcedure or surgery
Undergo RALP
diffuse optical imagingOther
Also called diffuse optical spectroscopy, diffuse optical tomography, DOI, near infrared optical tomography
Undergo IOOI
pharmacological studyOther
Also called pharmacological studies
Correlative studies
Laboratory BiomarkerOther
Correlative studies
QuestionnaireOther
Ancillary studies

Study groups in NCT02048150
Study group	Role	What they receive
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. Receives: Biological: anti-PSMA monoclonal antibody MDX1201-A488; Procedure: robot-assisted laparoscopic surgery; Other: diffuse optical imaging; Other: pharmacological study; Other: Laboratory Biomarker; Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 20151 Feb 2023

First posted29 Jan 2014 (estimated)
Study start5 Oct 2015
Primary completion10 May 2018
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02048150
Sponsor's protocol ID: 13405
Other IDs: NCI-2013-02476, 13405
Status last verified: Oct 2026
First submitted: 24 Jan 2014
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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