A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
NCT ID: NCT01667536
Last Updated: 2017-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2012-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Drug: 99mTc-MIP-1404
20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Interventions
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Drug: 99mTc-MIP-1404
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
21 Years
MALE
No
Sponsors
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Molecular Insight Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas Scherr, M.D.
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital-Cornell
Jeffrey Karnes, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Kevin Slawin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Vanguard Urologic Research Foundation
Thomas Keane, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Edouard Trabulsi, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University / Jefferson Urology Associates
David Jarrard, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
William Ellis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Judd Moul, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Eric Klein, MD
Role: PRINCIPAL_INVESTIGATOR
Glickman Urology & Kidney Institute, Cleveland Clinic
Bertram Yuh, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope National Cancer Center
Steven Joniau, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Alberto Briganti, MD
Role: PRINCIPAL_INVESTIGATOR
Vita-Salute University San Raffaele
Paolo Gontero, MD
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Mikhail I Shkolnik, MD
Role: PRINCIPAL_INVESTIGATOR
Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
Petr A Karlov, MD
Role: PRINCIPAL_INVESTIGATOR
St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
Vsevolod B Matveev, MD
Role: PRINCIPAL_INVESTIGATOR
Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
Boris Ya Alexeev, MD
Role: PRINCIPAL_INVESTIGATOR
Moscow Oncology Research Institute n.a. P.A. Hertsen
Sergey V Mishugin, MD
Role: PRINCIPAL_INVESTIGATOR
City Clinical Hospital # 57
Oleg B Karyakin
Role: PRINCIPAL_INVESTIGATOR
Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
Alexander K Nosov, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
Sergey B Petrov, MD
Role: PRINCIPAL_INVESTIGATOR
All-Russia Centre for Urgent Care and Radiation Medicine named after A.M. Nikiforov under the Ministry of the Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters
Milan Hora, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Plzen, Department of Urology
Josef Stolz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Motol, Clinic of Urology
Vladimir Student, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Olomouc, Clinic of Urology
Marek Krolupper, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Na Bulovce, Department of Urology
Michael Pesl,, MD
Role: PRINCIPAL_INVESTIGATOR
General University Hospital in Prague, Clinic of Urology
Roman Zachoval,, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Thomayer's Hospital
Marcin Matuszewski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Clinical Centre, Department of Urology
Henryk Zielinski, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Plzen, Department of Urology
Jerzy Sokolowski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Provincial Specialist Hospital in Wroclaw, Department of Urology
Tomasz Szydelko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
4th Military Teaching Hospital and Polyclinic,
Geza Boszormenyi-Nagy, MD
Role: PRINCIPAL_INVESTIGATOR
Bajcsy-Zsilinszky Hospital, Department of Urology
Peter Tenke, MD
Role: PRINCIPAL_INVESTIGATOR
Jahn Ferenc South Pest Hospital, Department of Urology
Istvan Buzogany, MD
Role: PRINCIPAL_INVESTIGATOR
Peterfy Sandor Street Hospital, Department of Urology
Michiel Sedelaar, MD
Role: PRINCIPAL_INVESTIGATOR
UMC St. Radboud Nijmegen
Locations
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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
4th Military Teaching Hospital and Polyclinic,
Wroclaw, , Poland
"Provincial Specialist Hospital in Wroclaw, Department of Urology
Wroclaw, , Poland
City Clinical Hospital # 57
Moscow, , Russia
Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
Moscow, , Russia
Moscow Oncology Research Institute n.a. P.A. Hertsen
Moscow, , Russia
Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
Obninsk, , Russia
All-Russia Centre for Urgent Care and Radiation Medicine named after A.M. Nikiforov under the Ministry of the Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters
Saint Petersburg, , Russia
Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
Saint Petersburg, , Russia
Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
Saint Petersburg, , Russia
St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
Saint Petersburg, , Russia
Countries
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References
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American Cancer Society, Inc., Surveillance Research; Cancer Facts & Figures, 2012
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
Hovels AM, Heesakkers RA, Adang EM, Jager GJ, Strum S, Hoogeveen YL, Severens JL, Barentsz JO. The diagnostic accuracy of CT and MRI in the staging of pelvic lymph nodes in patients with prostate cancer: a meta-analysis. Clin Radiol. 2008 Apr;63(4):387-95. doi: 10.1016/j.crad.2007.05.022. Epub 2008 Feb 4.
Pinto JT, Suffoletto BP, Berzin TM, Qiao CH, Lin S, Tong WP, May F, Mukherjee B, Heston WD. Prostate-specific membrane antigen: a novel folate hydrolase in human prostatic carcinoma cells. Clin Cancer Res. 1996 Sep;2(9):1445-51.
Smith-Jones PM, Vallabahajosula S, Goldsmith SJ, Navarro V, Hunter CJ, Bastidas D, Bander NH. In vitro characterization of radiolabeled monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen. Cancer Res. 2000 Sep 15;60(18):5237-43.
Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.
Murphy GP, Elgamal AA, Su SL, Bostwick DG, Holmes EH. Current evaluation of the tissue localization and diagnostic utility of prostate specific membrane antigen. Cancer. 1998 Dec 1;83(11):2259-69.
Ghosh A, Heston WD. Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer. J Cell Biochem. 2004 Feb 15;91(3):528-39. doi: 10.1002/jcb.10661.
Perner S, Hofer MD, Kim R, Shah RB, Li H, Moller P, Hautmann RE, Gschwend JE, Kuefer R, Rubin MA. Prostate-specific membrane antigen expression as a predictor of prostate cancer progression. Hum Pathol. 2007 May;38(5):696-701. doi: 10.1016/j.humpath.2006.11.012. Epub 2007 Feb 22.
Silver DA, Pellicer I, Fair WR, Heston WD, Cordon-Cardo C. Prostate-specific membrane antigen expression in normal and malignant human tissues. Clin Cancer Res. 1997 Jan;3(1):81-5.
Luthi-Carter R, Barczak AK, Speno H, Coyle JT. Molecular characterization of human brain N-acetylated alpha-linked acidic dipeptidase (NAALADase). J Pharmacol Exp Ther. 1998 Aug;286(2):1020-5.
Troyer JK, Beckett ML, Wright GL Jr. Detection and characterization of the prostate-specific membrane antigen (PSMA) in tissue extracts and body fluids. Int J Cancer. 1995 Sep 4;62(5):552-8. doi: 10.1002/ijc.2910620511.
Chang SS, Reuter VE, Heston WD, Bander NH, Grauer LS, Gaudin PB. Five different anti-prostate-specific membrane antigen (PSMA) antibodies confirm PSMA expression in tumor-associated neovasculature. Cancer Res. 1999 Jul 1;59(13):3192-8.
Maresca KP, Hillier SM, Femia FJ, Keith D, Barone C, Joyal JL, Zimmerman CN, Kozikowski AP, Barrett JA, Eckelman WC, Babich JW. A series of halogenated heterodimeric inhibitors of prostate specific membrane antigen (PSMA) as radiolabeled probes for targeting prostate cancer. J Med Chem. 2009 Jan 22;52(2):347-57. doi: 10.1021/jm800994j.
Hillier SM, Maresca KP, Femia FJ, Marquis JC, Foss CA, Nguyen N, Zimmerman CN, Barrett JA, Eckelman WC, Pomper MG, Joyal JL, Babich JW. Preclinical evaluation of novel glutamate-urea-lysine analogues that target prostate-specific membrane antigen as molecular imaging pharmaceuticals for prostate cancer. Cancer Res. 2009 Sep 1;69(17):6932-40. doi: 10.1158/0008-5472.CAN-09-1682. Epub 2009 Aug 25.
Godoy G, Chong KT, Cronin A, Vickers A, Laudone V, Touijer K, Guillonneau B, Eastham JA, Scardino PT, Coleman JA. Extent of pelvic lymph node dissection and the impact of standard template dissection on nomogram prediction of lymph node involvement. Eur Urol. 2011 Aug;60(2):195-201. doi: 10.1016/j.eururo.2011.01.016. Epub 2011 Jan 18.
Rao JN, Scott AJ. A simple method for the analysis of clustered binary data. Biometrics. 1992 Jun;48(2):577-85.
Durkalski VL, Palesch YY, Lipsitz SR, Rust PF. Analysis of clustered matched-pair data for a non-inferiority study design. Stat Med. 2003 Jan 30;22(2):279-90. doi: 10.1002/sim.1385.
Hillier SM, Maresca KP, Lu G, Merkin RD, Marquis JC, Zimmerman CN, Eckelman WC, Joyal JL, Babich JW. 99mTc-labeled small-molecule inhibitors of prostate-specific membrane antigen for molecular imaging of prostate cancer. J Nucl Med. 2013 Aug;54(8):1369-76. doi: 10.2967/jnumed.112.116624. Epub 2013 Jun 3.
Other Identifiers
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MIP-1404-201
Identifier Type: -
Identifier Source: org_study_id
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