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

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City of Hope

Status and phase

Completed
Phase 1

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02048150
NCI-2013-02476 (Registry Identifier)
13405

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

Male

Ages

36 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Diagnostic (MDX1201-A488, IOOI, RALP)
Experimental group
Description:
Patients receive anti-PSMA monoclonal antibody MDX1201-A488 IV over 30 minutes on day 1 and undergo IOOI during RALP on day 3.
Treatment:
Other: pharmacological study
Other: Questionnaire
Other: diffuse optical imaging
Procedure: robot-assisted laparoscopic surgery
Biological: anti-PSMA monoclonal antibody MDX1201-A488
Other: Laboratory Biomarker

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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