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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Drug: 99mTc-MIP-1404
Sponsored by
Molecular Insight Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring PROSTATE CANCER, HIGH-RISK, PROSTATECTOMY SURGERY, NEWLY DIAGNOSED

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope National Cancer Center
  • Mayo Clinic
  • New York Presbyterian Hospital - Cornell
  • Duke University Medical Center
  • Glickman Urology & Kidney Institute, Cleveland Clinic
  • Thomas Jefferson University / Jefferson Urology Associates
  • Medical University of South Carolina
  • University of Texas Vanguard Urologic Research Foundation
  • University of Washington School of Medicine
  • University of Wisconsin
  • University Hospitals Leuven
  • University Hospital Olomouc, Clinic of Urology
  • University Hospital Plzen, Department of Urology
  • General University Hospital in Prague, Clinic of Urology
  • Thomayer's Hospital
  • University Hospital Motol, Clinic of Urology
  • Hospital Na Bulovce, Department of Urology
  • Bajcsy-Zsilinszky Hospital, Department of Urology
  • Peterfy Sandor Street Hospital, Department of Urology
  • Jahn Ferenc South Pest Hospital, Department of Urology
  • Vita-Salute University San Raffaele
  • University of Turin
  • UMC St. Radboud Nijmegen
  • University Clinical Centre, Department of Urology
  • University Hospital Plzen, Department of Urology
  • 4th Military Teaching Hospital and Polyclinic,
  • "Provincial Specialist Hospital in Wroclaw, Department of Urology
  • City Clinical Hospital # 57
  • Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
  • Moscow Oncology Research Institute n.a. P.A. Hertsen
  • Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
  • 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
  • Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
  • Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
  • St. Petersburg State Public Medical Institution: "Clinical Oncological Center"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug: 99mTc-MIP-1404

Arm Description

20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Outcomes

Primary Outcome Measures

Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.
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
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
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
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.
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.
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.

Full Information

First Posted
August 13, 2012
Last Updated
December 14, 2016
Sponsor
Molecular Insight Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01667536
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecular Insight Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PROSTATE CANCER, HIGH-RISK, PROSTATECTOMY SURGERY, NEWLY DIAGNOSED

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: 99mTc-MIP-1404
Arm Type
Experimental
Arm Description
20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Intervention Type
Drug
Intervention Name(s)
Drug: 99mTc-MIP-1404
Other Intervention Name(s)
MIP-1404
Intervention Description
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Primary Outcome Measure Information:
Title
Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.
Description
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.
Time Frame
Within 3-6 hours of dosing SPECT/CT images will be taken
Secondary Outcome Measure Information:
Title
Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes
Description
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.
Time Frame
Within 3-6 hours of dosing SPECT/CT images will be taken
Title
Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland
Description
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.
Time Frame
Within 3-6 hours of dosing SPECT/CT images will be taken
Title
Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions
Description
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.
Time Frame
Within 3-6 hours of dosing SPECT/CT images will be taken
Title
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.
Description
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.
Time Frame
Within 3-6 hours of dosing SPECT/CT images will be taken
Title
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.
Description
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.
Time Frame
Within 3-6 hours of dosing SPECT/CT images will be taken

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Scherr, M.D.
Organizational Affiliation
New York Presbyterian Hospital-Cornell
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Karnes, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Slawin, MD
Organizational Affiliation
University of Texas Vanguard Urologic Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Keane, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edouard Trabulsi, MD
Organizational Affiliation
Thomas Jefferson University / Jefferson Urology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Jarrard, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Ellis, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judd Moul, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Klein, MD
Organizational Affiliation
Glickman Urology & Kidney Institute, Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertram Yuh, MD
Organizational Affiliation
City of Hope National Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Joniau, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Briganti, MD
Organizational Affiliation
Vita-Salute University San Raffaele
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Gontero, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mikhail I Shkolnik, MD
Organizational Affiliation
Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petr A Karlov, MD
Organizational Affiliation
St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vsevolod B Matveev, MD
Organizational Affiliation
Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boris Ya Alexeev, MD
Organizational Affiliation
Moscow Oncology Research Institute n.a. P.A. Hertsen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergey V Mishugin, MD
Organizational Affiliation
City Clinical Hospital # 57
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oleg B Karyakin
Organizational Affiliation
Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander K Nosov, MD
Organizational Affiliation
Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergey B Petrov, MD
Organizational 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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Milan Hora, MD, PhD
Organizational Affiliation
University Hospital Plzen, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josef Stolz, MD
Organizational Affiliation
University Hospital Motol, Clinic of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vladimir Student, MD, PhD
Organizational Affiliation
University Hospital Olomouc, Clinic of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marek Krolupper, MD
Organizational Affiliation
Hospital Na Bulovce, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Pesl,, MD
Organizational Affiliation
General University Hospital in Prague, Clinic of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roman Zachoval,, MD, PhD, MBA
Organizational Affiliation
Thomayer's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcin Matuszewski, MD, PhD
Organizational Affiliation
University Clinical Centre, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henryk Zielinski, MD
Organizational Affiliation
University Hospital Plzen, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerzy Sokolowski, MD, PhD
Organizational Affiliation
Provincial Specialist Hospital in Wroclaw, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomasz Szydelko, MD, PhD
Organizational Affiliation
4th Military Teaching Hospital and Polyclinic,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geza Boszormenyi-Nagy, MD
Organizational Affiliation
Bajcsy-Zsilinszky Hospital, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Tenke, MD
Organizational Affiliation
Jahn Ferenc South Pest Hospital, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Istvan Buzogany, MD
Organizational Affiliation
Peterfy Sandor Street Hospital, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michiel Sedelaar, MD
Organizational Affiliation
UMC St. Radboud Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope National Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Glickman Urology & Kidney Institute, Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University / Jefferson Urology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29435
Country
United States
Facility Name
University of Texas Vanguard Urologic Research Foundation
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital Olomouc, Clinic of Urology
City
Olomouc
ZIP/Postal Code
779 00
Country
Czech Republic
Facility Name
University Hospital Plzen, Department of Urology
City
Plzen
ZIP/Postal Code
30599
Country
Czech Republic
Facility Name
General University Hospital in Prague, Clinic of Urology
City
Prague
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Thomayer's Hospital
City
Prague
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
University Hospital Motol, Clinic of Urology
City
Prague
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Hospital Na Bulovce, Department of Urology
City
Prague
ZIP/Postal Code
180 01
Country
Czech Republic
Facility Name
Bajcsy-Zsilinszky Hospital, Department of Urology
City
Budapest
ZIP/Postal Code
8991
Country
Hungary
Facility Name
Peterfy Sandor Street Hospital, Department of Urology
City
Budapest
ZIP/Postal Code
H-1076
Country
Hungary
Facility Name
Jahn Ferenc South Pest Hospital, Department of Urology
City
Budapest
ZIP/Postal Code
H1204
Country
Hungary
Facility Name
Vita-Salute University San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
University of Turin
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
UMC St. Radboud Nijmegen
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
University Clinical Centre, Department of Urology
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
University Hospital Plzen, Department of Urology
City
Warsaw
ZIP/Postal Code
00909
Country
Poland
Facility Name
4th Military Teaching Hospital and Polyclinic,
City
Wroclaw
ZIP/Postal Code
50981
Country
Poland
Facility Name
"Provincial Specialist Hospital in Wroclaw, Department of Urology
City
Wroclaw
ZIP/Postal Code
51124
Country
Poland
Facility Name
City Clinical Hospital # 57
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow Oncology Research Institute n.a. P.A. Hertsen
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
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
ZIP/Postal Code
197374
Country
Russian Federation
Facility Name
Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation

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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

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