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This is a single arm, open label study of up to 24 high risk prostate cancer patients scheduled for prostatectomy and/or 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/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 (±3) mCi of study drug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-MIP-1404 | Drug | 20 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 | 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology. | Post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose | Summary tables will present change from pre-dose to post-dose vital signs measurements. | Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection |
| Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression |
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Inclusion Criteria:
Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:
Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery.
Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas S Scherr, MD | New York Presbyterian Hospital - Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15564406 | Background | Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672. | |
| 18405751 | Background | Swindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2008 May;179(5 Suppl):S47-51. doi: 10.1016/j.juro.2008.03.137. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000595576 | technetium 99m 1-(1-(2-(bis(carboxymethyl)amino)-2-oxoethyl)-1H-imidazol-2-yl)-2-((1-(2-(bis(carboxymethyl)amino)-2-oxoethyl)-1H-imidazol-2-yl)methyl)-9,14-dioxo-2,8,13,15-tetraazaoctadecane-7,12,16,18-tetracarboxylic acid) |
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99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology. |
| Post-procedure |
| Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs) | TEAEs will be summarized by the Medical Dictionary for Regulatory Activities (MedDRA) body system and preferred term, by intensity, and by causal relationship to study agent. | Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks |
| 11962189 | Background | Hocht S, Wiegel T, Bottke D, Jentsch H, Sternemann M, Rosenthal P, Hinkelbein W. Computed tomogram prior to prostatectomy. Advantage in defining planning target volumes for postoperative adjuvant radiotherapy in patients with stage C prostate cancer? Strahlenther Onkol. 2002 Mar;178(3):134-8. doi: 10.1007/s00066-002-0896-9. |
| 11007527 | Background | Kotzerke J, Prang J, Neumaier B, Volkmer B, Guhlmann A, Kleinschmidt K, Hautmann R, Reske SN. Experience with carbon-11 choline positron emission tomography in prostate carcinoma. Eur J Nucl Med. 2000 Sep;27(9):1415-9. doi: 10.1007/s002590000309. |
| 9816319 | Background | 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. |
| 11016653 | Background | 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. |
| 14755683 | Background | 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. doi: 10.1002/jcb.10661. |
| 16555021 | Background | 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. doi: 10.1007/s00268-005-0544-5. |
| 17290063 | Background | Milowsky MI, Nanus DM, Kostakoglu L, Sheehan CE, Vallabhajosula S, Goldsmith SJ, Ross JS, Bander NH. Vascular targeted therapy with anti-prostate-specific membrane antigen monoclonal antibody J591 in advanced solid tumors. J Clin Oncol. 2007 Feb 10;25(5):540-7. doi: 10.1200/JCO.2006.07.8097. |
| 19706750 | Background | 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. doi: 10.1158/0008-5472.CAN-09-1682. Epub 2009 Aug 25. |
| 18474004 | Background | Olson WC, Heston WD, Rajasekaran AK. Clinical trials of cancer therapies targeting prostate-specific membrane antigen. Rev Recent Clin Trials. 2007 Sep;2(3):182-90. doi: 10.2174/157488707781662724. |
| 15840561 | Background | Rajasekaran AK, Anilkumar G, Christiansen JJ. Is prostate-specific membrane antigen a multifunctional protein? Am J Physiol Cell Physiol. 2005 May;288(5):C975-81. doi: 10.1152/ajpcell.00506.2004. |
| 15948673 | Background | Slovin SF. Targeting novel antigens for prostate cancer treatment: focus on prostate-specific membrane antigen. Expert Opin Ther Targets. 2005 Jun;9(3):561-70. doi: 10.1517/14728222.9.3.561. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |