Clinical trial NCT01667536: A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: PROSTATE CANCER
HIGH-RISK
PROSTATECTOMY SURGERY
NEWLY DIAGNOSED
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 105
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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.

Primary outcomes:
measure: Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
Secondary outcomes:
measure: Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
measure: Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
measure: Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
measure: Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
measure: Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.
timeFrame: Within 3-6 hours of dosing SPECT/CT images will be taken
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Cancer Center
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York City
country: United States
facility: New York Presbyterian Hospital - Cornell
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Glickman Urology & Kidney Institute, Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University / Jefferson Urology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas Vanguard Urologic Research Foundation
state: Texas
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc, Clinic of Urology
city: Plzen
country: Czech Republic
facility: University Hospital Plzen, Department of Urology
city: Prague
country: Czech Republic
facility: General University Hospital in Prague, Clinic of Urology
city: Prague
country: Czech Republic
facility: Thomayer's Hospital
city: Prague
country: Czech Republic
facility: University Hospital Motol, Clinic of Urology
city: Prague
country: Czech Republic
facility: Hospital Na Bulovce, Department of Urology
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital, Department of Urology
city: Budapest
country: Hungary
facility: Peterfy Sandor Street Hospital, Department of Urology
city: Budapest
country: Hungary
facility: Jahn Ferenc South Pest Hospital, Department of Urology
city: Milan
country: Italy
facility: Vita-Salute University San Raffaele
city: Torino
country: Italy
facility: University of Turin
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud Nijmegen
city: Gdansk
country: Poland
facility: University Clinical Centre, Department of Urology
city: Warsaw
country: Poland
facility: University Hospital Plzen, Department of Urology
city: Wroclaw
country: Poland
facility: 4th Military Teaching Hospital and Polyclinic,
city: Wroclaw
country: Poland
facility: "Provincial Specialist Hospital in Wroclaw, Department of Urology
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 57
city: Moscow
country: Russian Federation
facility: Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
city: Moscow
country: Russian Federation
facility: Moscow Oncology Research Institute n.a. P.A. Hertsen
city: Obninsk
country: Russian Federation
facility: Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
city: Saint-Petersburg
country: Russian Federation
facility: 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
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
city: Saint-Petersburg
country: Russian Federation
facility: Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
Study officials:
affiliation: New York Presbyterian Hospital-Cornell
name: Douglas Scherr, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Jeffrey Karnes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Vanguard Urologic Research Foundation
name: Kevin Slawin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Thomas Keane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University / Jefferson Urology Associates
name: Edouard Trabulsi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: David Jarrard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: William Ellis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Judd Moul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glickman Urology & Kidney Institute, Cleveland Clinic
name: Eric Klein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Hope National Cancer Center
name: Bertram Yuh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Steven Joniau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vita-Salute University San Raffaele
name: Alberto Briganti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Paolo Gontero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
name: Mikhail I Shkolnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
name: Petr A Karlov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
name: Vsevolod B Matveev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow Oncology Research Institute n.a. P.A. Hertsen
name: Boris Ya Alexeev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: City Clinical Hospital # 57
name: Sergey V Mishugin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
name: Oleg B Karyakin
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
name: Alexander K Nosov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Sergey B Petrov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Plzen, Department of Urology
name: Milan Hora, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Motol, Clinic of Urology
name: Josef Stolz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Olomouc, Clinic of Urology
name: Vladimir Student, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Na Bulovce, Department of Urology
name: Marek Krolupper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital in Prague, Clinic of Urology
name: Michael Pesl,, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomayer's Hospital
name: Roman Zachoval,, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinical Centre, Department of Urology
name: Marcin Matuszewski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Plzen, Department of Urology
name: Henryk Zielinski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Provincial Specialist Hospital in Wroclaw, Department of Urology
name: Jerzy Sokolowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 4th Military Teaching Hospital and Polyclinic,
name: Tomasz Szydelko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bajcsy-Zsilinszky Hospital, Department of Urology
name: Geza Boszormenyi-Nagy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jahn Ferenc South Pest Hospital, Department of Urology
name: Peter Tenke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peterfy Sandor Street Hospital, Department of Urology
name: Istvan Buzogany, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC St. Radboud Nijmegen
name: Michiel Sedelaar, MD
role: PRINCIPAL_INVESTIGATOR
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