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

August 13, 2012
November 12, 2013
August 2012
December 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01667536 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • 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.
Same as current
 
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
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

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
Drug: Drug: 99mTc-MIP-1404
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Experimental: Drug: 99mTc-MIP-1404
20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Intervention: Drug: Drug: 99mTc-MIP-1404

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Male
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Russian Federation,   Hungary,   United States,   Czech Republic,   Netherlands,   Belgium,   Italy
 
NCT01667536
MIP-1404-201
No
Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals, Inc.
Not Provided
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Principal Investigator: Petr A Karlov, MD St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
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Principal Investigator: Boris Ya Alexeev, MD Moscow Oncology Research Institute n.a. P.A. Hertsen
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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
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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
Molecular Insight Pharmaceuticals, Inc.
November 2013

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