intra-operative optical imaging with mdx1201-a488 in patients with prostate cancer

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

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.

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