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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712829
• Other study ID #: TX-P101
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2008
• Last updated: October 7, 2011
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2011
• Source: Molecular Insight Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 123-I-MIP-1072
10 mCi intravenous injection given one time during the study
• 123-I-MIP-1095
10 mCi intravenous injection given one time during the study

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutes - Neuroradiology Division	Baltimore	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	New York Weill Cornell Medical Center - New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Molecular Insight Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Secondary	To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.			No
Secondary	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.			Yes
Secondary	Optimize imaging parameters			No