Clinical trial NCT02048150: Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer
Official title: Intra-operative Optical Imaging Utilizing Anti-PSMA (Prostate Specific Membrane Antigen) Fluorescent Antibody During Robotic Assisted Laparoscopic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma of the Prostate
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-01-29
Enrollment: 7
Sex: MALE
Minimum age (years): 36
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Imaging ability of anti-PMSA monoclonal antibody MDX1201-A488
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Ali Zhumkhawala, MD
role: PRINCIPAL_INVESTIGATOR
References: