Clinical trial NCT00712829: Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Prostate cancer
Imaging
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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) 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.


Eligibility 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.

Primary outcomes:
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 outcomes:
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.
measure: 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.
measure: Optimize imaging parameters
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutes - Neuroradiology Division
state: Maryland
city: New York
country: United States
facility: New York Weill Cornell Medical Center - New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: