A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.

Key facts

Study ID

NCT01667536

Run by

Molecular Insight Pharmaceuticals, Inc.

People needed

105

Starts

2012-08-01

Expected to finish

2013-12-01

Last updated by the study team

2017-02-07

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male aged 21 years or older.
• Ability to provide signed informed consent and willingness to comply with protocol requirements.
• Biopsy confirmed presence of adenocarcinoma of the prostate gland.
• At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130.
• Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
• Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection.

You may not qualify if…

• Participating would significantly delay the scheduled standard of care therapy.
• Administered a radioisotope within 5 physical half lives prior to study drug injection.
• Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
• Have a contraindication for MR imaging.

Where it is running

• City of Hope National Cancer Center — Duarte, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• New York Presbyterian Hospital - Cornell — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Glickman Urology & Kidney Institute, Cleveland Clinic — Cleveland, Ohio, United States
• Thomas Jefferson University / Jefferson Urology Associates — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Vanguard Urologic Research Foundation — Houston, Texas, United States
• University of Washington School of Medicine — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• University Hospitals Leuven — Leuven, Belgium
• University Hospital Olomouc, Clinic of Urology — Olomouc, Czechia
• University Hospital Plzen, Department of Urology — Pilsen, Czechia
• General University Hospital in Prague, Clinic of Urology — Prague, Czechia
• Thomayer's Hospital — Prague, Czechia
• University Hospital Motol, Clinic of Urology — Prague, Czechia
• Hospital Na Bulovce, Department of Urology — Prague, Czechia
• Bajcsy-Zsilinszky Hospital, Department of Urology — Budapest, Hungary
• Peterfy Sandor Street Hospital, Department of Urology — Budapest, Hungary
• Jahn Ferenc South Pest Hospital, Department of Urology — Budapest, Hungary
• Vita-Salute University San Raffaele — Milan, Italy
• University of Turin — Torino, Italy
• UMC St. Radboud Nijmegen — Nijmegen, Netherlands
• University Clinical Centre, Department of Urology — Gdansk, Poland
• University Hospital Plzen, Department of Urology — Warsaw, Poland

Full record on ClinicalTrials.gov

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