A Phase 2 Diagnostic Imaging Study With 99mTc-MIP-1404 in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01667536
First received: August 13, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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:
  • 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 ] [ Designated as safety issue: No ]
    Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes(as determined by histopathology) in patients undergoing standard of care prostatectomy with extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.

  • Clinical safety of 99mTc-MIP-1404 [ Time Frame: Vital signs will be taken at Pre-Dose and Post-Dose as well as between 3-6 hours post-dose. Lab samples: will be taken at Screening and Pre-Surgery (within 21 days of dosing) ] [ Designated as safety issue: Yes ]
    Clinical laboratory tests will include hematology, clinical chemistry, and PSA. Vital signs will include heart rate and blood pressure.


Secondary Outcome Measures:
  • Ability of 99mTc-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 ] [ Designated as safety issue: No ]
    Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy

  • Ability of 99mTc-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 ] [ Designated as safety issue: No ]
    To obtain tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph nodes

  • Ability of 99mTc-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 ] [ Designated as safety issue: No ]
    To obtain tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph nodes

  • Compare performance of 99mTc-MIP-1404 against MRI for detection of prostate cancer within the prostate gland. [ Time Frame: The MRI will take place at Screening. SPECT/CT imaging will take place within 3-6 hours of dosing ] [ Designated as safety issue: No ]
    To obtain MRI images (pre-dose) and 99m1404 SPECT/CT images (post-dose) for comparison.

  • Compare performance of 99mTc-MIP-1404 against MRI for detection of metastatic prostate cancer within pelvic lymph nodes. [ Time Frame: The MRI will take place at Screening. SPECT/CT imaging will take place within 3-6 hours of dosing ] [ Designated as safety issue: No ]
    To obtain MRI images (pre-dose) and 99m1404 SPECT/CT images (post-dose) for comparison.


Other Outcome Measures:
  • PSMA expression relative to 99mTc-MIP-1404 imaging in a sub-set of surgical specimens. [ Time Frame: PSMA expression analysis will be conducted upon completion of enrollment ] [ Designated as safety issue: No ]
    This is an exploratory objective in which PSMA staining will be conducted on a sub-set of patients' surgical specimens. To minimize variability PSMA staining will be analyzed centrally post-enrollment completion with all specimens included to be stained at the same time.

  • Compare performance of 99mTc-MIP-1404 against MRI for detection of the extent and location of prostate cancer within the prostate gland. [ Time Frame: The MRI will take place at Screening. SPECT/CT imaging will take place within 3-6 hours of dosing ] [ Designated as safety issue: No ]
    To obtain MRI images (pre-dose) and 99m1404 SPECT/CT images (post-dose) for comparison.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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:
Ahmedin J, et al. Global Cancer Statistics. CA, Cancer J Clin; 2011; 61:69-90.

Additional 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
Study First Received: August 13, 2012
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014