A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer. Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests) performed during the subsequent 24 hours. Two weeks later, patients will return for additional safety assessments and will receive ProstaScint® if they don't already have a pre-existing ProstaScint scan. Final assessments will be performed two weeks after the ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint® scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and imaging studies repeated.

Key facts

Study ID

NCT00992745

Run by

Molecular Insight Pharmaceuticals, Inc.

People needed

24

Starts

2009-10-01

Expected to finish

2011-09-01

Last updated by the study team

2011-10-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Karnofsky performance status of < 50
• Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants or 12 months for 125I implants
• Subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
• Subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study
• Any treatment with radiopharmaceuticals, e.g. Strontium 89 and Samarium 153 within 6 months prior to enrollment
• Ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. Patients who demonstrate an antiandrogen withdrawal response, defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non steroidal anti androgen, are not eligible until the PSA rises above the nadir observed after anti androgen withdrawal
• Initiation of bisphosphonate therapy within 28 days prior to enrollment. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study
• Subject has 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
• Subject is determined by the Investigator to be clinically unsuitable for the study
• If the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response

Where it is running

• West Coast Radiology Centers — Laguna Niguel, California, United States
• Pacific Coast Imaging — Newport Beach, California, United States
• University of California - San Francisco — San Francisco, California, United States
• University of Maryland — Baltimore, Maryland, United States
• New York Presbyterian Hospital - Weill Cornell Medical College — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Vanguard Urologic Research Foundation — Houston, Texas, United States

Full record on ClinicalTrials.gov

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