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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667536
First Posted: August 17, 2012
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: Drug: 99mTc-MIP-1404 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

Resource links provided by NLM:


Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland. [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]
    For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.


Secondary Outcome Measures:
  • Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]
    For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.

  • Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]
    For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.

  • Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]
    For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.

  • Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland. [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]
    Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.

  • Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes. [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]
    Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.


Enrollment: 105
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: 99mTc-MIP-1404
20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: Drug: 99mTc-MIP-1404
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Other Name: MIP-1404

Detailed Description:
This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667536


  Show 35 Study Locations
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
Principal Investigator: Douglas Scherr, M.D. New York Presbyterian Hospital-Cornell
Principal Investigator: Jeffrey Karnes, MD Mayo Clinic
Principal Investigator: Kevin Slawin, MD University of Texas Vanguard Urologic Research Foundation
Principal Investigator: Thomas Keane, MD Medical University of South Carolina
Principal Investigator: Edouard Trabulsi, MD Thomas Jefferson University / Jefferson Urology Associates
Principal Investigator: David Jarrard, MD University of Wisconsin, Madison
Principal Investigator: William Ellis, MD University of Washington
Principal Investigator: Judd Moul, MD Duke University
Principal Investigator: Eric Klein, MD Glickman Urology & Kidney Institute, Cleveland Clinic
Principal Investigator: Bertram Yuh, MD City of Hope National Cancer Center
Principal Investigator: Steven Joniau, MD University Hospitals Leuven
Principal Investigator: Alberto Briganti, MD Vita-Salute University San Raffaele
Principal Investigator: Paolo Gontero, MD University of Turin, Italy
Principal Investigator: Mikhail I Shkolnik, MD Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
Principal Investigator: Petr A Karlov, MD St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
Principal Investigator: Vsevolod B Matveev, MD Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
Principal Investigator: Boris Ya Alexeev, MD Moscow Oncology Research Institute n.a. P.A. Hertsen
Principal Investigator: Sergey V Mishugin, MD City Clinical Hospital # 57
Principal Investigator: Oleg B Karyakin Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
Principal Investigator: Alexander K Nosov, MD Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
Principal Investigator: Sergey B Petrov, MD 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
Principal Investigator: Milan Hora, MD, PhD University Hospital Plzen, Department of Urology
Principal Investigator: Josef Stolz, MD University Hospital Motol, Clinic of Urology
Principal Investigator: Vladimir Student, MD, PhD University Hospital Olomouc, Clinic of Urology
Principal Investigator: Marek Krolupper, MD Hospital Na Bulovce, Department of Urology
Principal Investigator: Michael Pesl,, MD General University Hospital in Prague, Clinic of Urology
Principal Investigator: Roman Zachoval,, MD, PhD, MBA Thomayer's Hospital
Principal Investigator: Marcin Matuszewski, MD, PhD University Clinical Centre, Department of Urology
Principal Investigator: Henryk Zielinski, MD University Hospital Plzen, Department of Urology
Principal Investigator: Jerzy Sokolowski, MD, PhD Provincial Specialist Hospital in Wroclaw, Department of Urology
Principal Investigator: Tomasz Szydelko, MD, PhD 4th Military Teaching Hospital and Polyclinic,
Principal Investigator: Geza Boszormenyi-Nagy, MD Bajcsy-Zsilinszky Hospital, Department of Urology
Principal Investigator: Peter Tenke, MD Jahn Ferenc South Pest Hospital, Department of Urology
Principal Investigator: Istvan Buzogany, MD Peterfy Sandor Street Hospital, Department of Urology
Principal Investigator: Michiel Sedelaar, MD UMC St. Radboud Nijmegen
  More Information

Publications:
American Cancer Society, Inc., Surveillance Research; Cancer Facts & Figures, 2012

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01667536     History of Changes
Other Study ID Numbers: MIP-1404-201
First Submitted: August 13, 2012
First Posted: August 17, 2012
Results First Submitted: December 15, 2015
Results First Posted: March 30, 2016
Last Update Posted: February 7, 2017
Last Verified: December 2016

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
PROSTATE CANCER
HIGH-RISK
PROSTATECTOMY SURGERY
NEWLY DIAGNOSED

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases