We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00712829
First Posted: July 10, 2008
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
  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 (Participant)
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.

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.
  • 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00712829     History of Changes
Other Study ID Numbers: TX-P101
First Submitted: July 8, 2008
First Posted: July 10, 2008
Last Update Posted: October 12, 2011
Last Verified: October 2011

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