| August 13, 2012 |
| April 17, 2013 |
| August 2012 |
| August 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 |
- Hövels AM, Heesakkers RA, Adang EM, Jager GJ, Strum S, Hoogeveen YL, Severens JL, Barentsz JO. The diagnostic accuracy of CT and MRI in the staging of pelvic lymph nodes in patients with prostate cancer: a meta-analysis. Clin Radiol. 2008 Apr;63(4):387-95. Epub 2008 Feb 4. Review.
- Pinto JT, Suffoletto BP, Berzin TM, Qiao CH, Lin S, Tong WP, May F, Mukherjee B, Heston WD. Prostate-specific membrane antigen: a novel folate hydrolase in human prostatic carcinoma cells. Clin Cancer Res. 1996 Sep;2(9):1445-51.
- Smith-Jones PM, Vallabahajosula S, Goldsmith SJ, Navarro V, Hunter CJ, Bastidas D, Bander NH. In vitro characterization of radiolabeled monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen. Cancer Res. 2000 Sep 15;60(18):5237-43.
- Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36.
- Murphy GP, Elgamal AA, Su SL, Bostwick DG, Holmes EH. Current evaluation of the tissue localization and diagnostic utility of prostate specific membrane antigen. Cancer. 1998 Dec 1;83(11):2259-69. Review.
- Ghosh A, Heston WD. Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer. J Cell Biochem. 2004 Feb 15;91(3):528-39. Review.
- Perner S, Hofer MD, Kim R, Shah RB, Li H, Möller P, Hautmann RE, Gschwend JE, Kuefer R, Rubin MA. Prostate-specific membrane antigen expression as a predictor of prostate cancer progression. Hum Pathol. 2007 May;38(5):696-701. Epub 2007 Feb 22.
- Silver DA, Pellicer I, Fair WR, Heston WD, Cordon-Cardo C. Prostate-specific membrane antigen expression in normal and malignant human tissues. Clin Cancer Res. 1997 Jan;3(1):81-5.
- Luthi-Carter R, Barczak AK, Speno H, Coyle JT. Molecular characterization of human brain N-acetylated alpha-linked acidic dipeptidase (NAALADase). J Pharmacol Exp Ther. 1998 Aug;286(2):1020-5.
- Troyer JK, Beckett ML, Wright GL Jr. Detection and characterization of the prostate-specific membrane antigen (PSMA) in tissue extracts and body fluids. Int J Cancer. 1995 Sep 4;62(5):552-8.
- Chang SS, Reuter VE, Heston WD, Bander NH, Grauer LS, Gaudin PB. Five different anti-prostate-specific membrane antigen (PSMA) antibodies confirm PSMA expression in tumor-associated neovasculature. Cancer Res. 1999 Jul 1;59(13):3192-8.
- Maresca KP, Hillier SM, Femia FJ, Keith D, Barone C, Joyal JL, Zimmerman CN, Kozikowski AP, Barrett JA, Eckelman WC, Babich JW. A series of halogenated heterodimeric inhibitors of prostate specific membrane antigen (PSMA) as radiolabeled probes for targeting prostate cancer. J Med Chem. 2009 Jan 22;52(2):347-57.
- Hillier SM, Maresca KP, Femia FJ, Marquis JC, Foss CA, Nguyen N, Zimmerman CN, Barrett JA, Eckelman WC, Pomper MG, Joyal JL, Babich JW. Preclinical evaluation of novel glutamate-urea-lysine analogues that target prostate-specific membrane antigen as molecular imaging pharmaceuticals for prostate cancer. Cancer Res. 2009 Sep 1;69(17):6932-40. Epub 2009 Aug 25.
- Rao JN, Scott AJ. A simple method for the analysis of clustered binary data. Biometrics. 1992 Jun;48(2):577-85.
- Durkalski VL, Palesch YY, Lipsitz SR, Rust PF. Analysis of clustered matched-pair data for a non-inferiority study design. Stat Med. 2003 Jan 30;22(2):279-90.
|
| |
| Recruiting |
| 100 |
| October 2013 |
| August 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 |
|
|
| United States, Belgium, Czech Republic, Hungary, Italy, Netherlands, Poland, Russian Federation |
| |
| NCT01667536 |
| MIP-1404-201 |
| No |
| Molecular Insight Pharmaceuticals, Inc. |
| Molecular Insight Pharmaceuticals, Inc. |
| Not Provided
| 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 |
|
|
| Molecular Insight Pharmaceuticals, Inc. |
| April 2013 |
