Status:
COMPLETED
Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
Lead Sponsor:
Molecular Insight Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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) ...
Eligibility Criteria
Inclusion
- 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:
- PSA\> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00712829
Start Date
May 1 2008
End Date
January 1 2009
Last Update
October 12 2011
Active Locations (3)
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1
Johns Hopkins Medical Institutes - Neuroradiology Division
Baltimore, Maryland, United States, 21287
2
New York Weill Cornell Medical Center - New York Presbyterian Hospital
New York, New York, United States, 10021
3
Duke University Medical Center
Durham, North Carolina, United States, 27710