Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection

NCT01572701 | Completed Phase 1

• 1 other identifier: MIP-TcTx-P104
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose

  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

  Post-procedure

• Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs)

  Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks

Study Arms (1)

20 (±3) mCi of study drug

EXPERIMENTAL

Drug: 99mTc-MIP-1404

Interventions

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

20 (±3) mCi of study drug

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Patient has PSA value \>10 and clinical stage T2 or higher, and Gleason score 8, 9 or 10.
• Patient has PSA value \>20 and clinical stage T2 or higher, and Gleason score
• 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.

You may not qualify if:

• Participants for whom participating would significantly delay the scheduled standard of care therapy.
• Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
• Participants with 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.

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (13)

• 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.

  PMID: 15564406 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.

  PMID: 18405751 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.

  PMID: 11962189 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.

  PMID: 11007527 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.

  PMID: 9816319 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.

  PMID: 11016653 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.

  PMID: 14755683 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.

  PMID: 16555021 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.

  PMID: 17290063 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.

  PMID: 19706750 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.

  PMID: 18474004 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.

  PMID: 15840561 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.

  PMID: 15948673 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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)

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Douglas S Scherr, MD

  New York Presbyterian Hospital - Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: April 6, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (1)