Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents

A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen: Determination of I-123 Radiation Dosimetry for 123-I-MIP-1072 and 123-I-MIP-1095

This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 123-I-MIP-1072; Drug: 123-I-MIP-1095

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medical Institutes - Neuroradiology Division
  • New York
    • New York, New York, United States, 10021
      • New York Weill Cornell Medical Center - New York Presbyterian Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Have a prior histological diagnosis of prostate cancer.

• Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:

  1. PSA> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
  2. PSA> 20 if intact prostate
• Have platelet count of > 50,000/mm3
• Have neutrophil count of > 1,000/mm3
• Provide written informed consent and willing to comply with protocol requirements
• Greater than or equal to 18 years of age
• Can be on hormonal therapy if dose stable for > 90 days

Exclusion Criteria:

• Karnofsky performance status of <60
• Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
• Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants).
• Patient received external beam therapy or chemotherapy within the last 30 days
• Administered a radioisotope within 5 physical half lives prior to study enrollment
• Serum creatinine > 3.5 mg/dL
• Total bilirubin > 2.5 times the upper limit of normal
• Liver transaminases greater than 5x the upper limit of normal
• Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study
• Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
• Is determined by the Investigator that the patient is clinically unsuitable for the study
• Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later.	Drug: 123-I-MIP-1072; 10 mCi intravenous injection given one time during the study; Drug: 123-I-MIP-1095; 10 mCi intravenous injection given one time during the study
Experimental: 2; 123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later.	Drug: 123-I-MIP-1072; 10 mCi intravenous injection given one time during the study; Drug: 123-I-MIP-1095; 10 mCi intravenous injection given one time during the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease.

Secondary Outcome Measures

Outcome Measure
To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.
To evaluate the safety of administering a 10.0 mCi dose of 123-I-MIP-1072 and 123-I-MIP-1095 to patients with recurrent metastatic prostate cancer.
Optimize imaging parameters

Collaborators and Investigators

• Sponsor: Molecular Insight Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 9, 2008
• First Posted (Estimate): July 10, 2008

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 7, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Imaging; Prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: TX-P101