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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00712829
First received: July 8, 2008
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: 123-I-MIP-1072
Drug: 123-I-MIP-1095
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: Yes ]
  • Optimize imaging parameters [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712829

Locations
United States, Maryland
Johns Hopkins Medical Institutes - Neuroradiology Division
Baltimore, Maryland, United States, 21287
United States, New York
New York Weill Cornell Medical Center - New York Presbyterian Hospital
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00712829     History of Changes
Other Study ID Numbers: TX-P101
Study First Received: July 8, 2008
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
Prostate cancer
Imaging

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014