A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
- Conditions
- Prostate Cancer
- Registration Number
- NCT01667536
- Lead Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 105
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland. 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
Name Time Method Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes 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 Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes. 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.
Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland 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 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. 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.
Trial Locations
- Locations (34)
University Hospital Olomouc, Clinic of Urology
🇨🇿Olomouc, Czech Republic
Moscow Oncology Research Institute n.a. P.A. Hertsen
🇷🇺Moscow, Russian Federation
University Hospital Plzen, Department of Urology
🇵🇱Warsaw, Poland
Thomayer's Hospital
🇨🇿Prague, Czech Republic
Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
🇷🇺Saint-Petersburg, Russian Federation
Jahn Ferenc South Pest Hospital, Department of Urology
ðŸ‡ðŸ‡ºBudapest, Hungary
University Hospital Motol, Clinic of Urology
🇨🇿Prague, Czech Republic
Hospital Na Bulovce, Department of Urology
🇨🇿Prague, Czech Republic
University Clinical Centre, Department of Urology
🇵🇱Gdansk, Poland
4th Military Teaching Hospital and Polyclinic,
🇵🇱Wroclaw, Poland
City Clinical Hospital # 57
🇷🇺Moscow, Russian Federation
Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
🇷🇺Obninsk, Russian Federation
General University Hospital in Prague, Clinic of Urology
🇨🇿Prague, Czech Republic
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
UMC St. Radboud Nijmegen
🇳🇱Nijmegen, Netherlands
New York Presbyterian Hospital - Cornell
🇺🇸New York City, New York, United States
University Hospitals Leuven
🇧🇪Leuven, Belgium
City of Hope National Cancer Center
🇺🇸Duarte, California, United States
Bajcsy-Zsilinszky Hospital, Department of Urology
ðŸ‡ðŸ‡ºBudapest, Hungary
University of Turin
🇮🇹Torino, Italy
Glickman Urology & Kidney Institute, Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Thomas Jefferson University / Jefferson Urology Associates
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
Vita-Salute University San Raffaele
🇮🇹Milan, Italy
"Provincial Specialist Hospital in Wroclaw, Department of Urology
🇵🇱Wroclaw, Poland
Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
🇷🇺Moscow, 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
🇷🇺Saint-Petersburg, Russian Federation
St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
🇷🇺Saint-Petersburg, Russian Federation
Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
🇷🇺Saint-Petersburg, Russian Federation
University of Texas Vanguard Urologic Research Foundation
🇺🇸Houston, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Peterfy Sandor Street Hospital, Department of Urology
ðŸ‡ðŸ‡ºBudapest, Hungary