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

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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

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 May 22, 2013