Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

NCT02615067 | Completed Phase 3 DMC

• 1 other identifier: MIP-1404-3301
• Study Type: interventional
• Target: 531
• Locations: 2 countries
• Sites: 45

Brief Summary

99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) \[Cohort A\] or routine prostate biopsy \[Cohort B\]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.

Conditions

Prostate Cancer

Keywords

Diagnostic; Active surveillance; Very low risk; Imaging; PSMA; SPECT/CT; 99mTc; Newly Diagnosed; Prostatectomy; Biopsy

Outcome Measures

Primary Outcomes (2)

• Specificity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]

  Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes, if applicable, (as determined by histopathology) in patients undergoing RP (with or without extended pelvic lymph node dissection) or routine prostate biopsy. Pathology results will be used as the truth standard for all imaging analyses.

  Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken

• Sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]

  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 or without extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.

  Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken

Secondary Outcomes (3)

• Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]

  Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken

• Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]

  Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken

• Clinical safety of 99mTc-MIP-1404

  Changes in vital signs and clinical laboratory test results from time of screening until pre-surgery (Day 0 - 42). Treatment-emergent adverse events from study drug injection until pre-surgery or pre-biopsy (within 42 days)

Study Arms (1)

99mTc-MIP-1404 Injection

EXPERIMENTAL

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

Drug: 99mTc-MIP-1404 Injection; Diagnostic Test: Whole-Body Planar and pelvic SPECT/CT scan

Interventions

99mTc-MIP-1404 Injection DRUG

A single dose of 20 (±3) mCi intravenous (IV) injection of 99mTc-MIP-1404.

Also known as: 1404

99mTc-MIP-1404 Injection

Whole-Body Planar and pelvic SPECT/CT scan DIAGNOSTIC_TEST

A whole-body planar and pelvic SPECT/CT scan will be obtained 3-6 hours after injection of 99mTc-MIP-1404.

99mTc-MIP-1404 Injection

Eligibility Criteria

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

You may qualify if:

• Ability to provide informed consent and willingness to comply with protocol requirements
• Life expectancy ≥ 6 months
• Cohort A only:
• A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of enrollment showing adenocarcinoma of the prostate gland
• Within 90 days of consent, serum PSA ≤ 15.0 ng/mL or ≤ 7.5 ng/mL if on 5 α-reductase inhibitors.
• Candidates for active surveillance and/or a Gleason score ≤3+4
• Scheduled to undergo radical prostatectomy (RP) with or without pelvic lymph node dissection (PLND)
• Cohort B only:
• Very low risk (VLR) prostate cancer defined by 2016 NCCN Guideline criteria:
• T1c stage, and
• PSA \< 10 ng/mL, and
• Gleason score ≤ 6 with \< 3 biopsy cores cancer positive and ≤ 50% cancer in any core based on prior prostate biopsy within 24 months of enrollment, and
• PSA density \< 0.15 mg/mL/g
• Scheduled to undergo a reassessment of prostate cancer staging that includes prostate biopsy as part of routine follow-up

You may not qualify if:

• Subjects administered a radioisotope within 5 physical half-lives prior to study drug injection.
• Previous treatment with hormonal therapy, surgery (except biopsy), radiation therapy, LHRH analogs, and non-steroidal anti-androgens, for the treatment of prostate cancer or benign prostatic hyperplasia (BPH)
• Planned androgen or anti-androgen therapy prior to RP surgery or biopsy
• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, would significantly interfere with obtaining reliable data, achieving study objectives, or completing the study
• Malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (Ta stage transitional cell carcinoma bladder cancer with negative surveillance cystoscopy within the past 2 years may be included).

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.: lead

Study Sites (45)

City of Hope Cancer Center

Duarte, California, 91010, United States

Location

VA Greater Los Angeles Healthcare

Los Angeles, California, 90073, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Florida Urology Partners - Tampa Bay

Clearwater, Florida, 33612, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33765, United States

Location

University of Georgia / Regents Medical Center

Augusta, Georgia, 30912, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Louisiana State University Health Science Center

Shreveport, Louisiana, 71103, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Montgomery General Hospital

Olney, Maryland, 20832, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Northeast Urology Research

Concord, North Carolina, 28025, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Urologic Consultants of Southeastern PA, LLP

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-2640, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Rockledge, Pennsylvania, 19046, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29435, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98109, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Prostate Cancer Centre

Calgary, AB, Alberta, T2V 1P9, Canada

Location

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Cancer Care Nova Scotia

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Ottawa Hospital Research Institute, University of Ottawa

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MUHC

Montreal, Quebec, H4A 3J1, Canada

Location

Centre d'imagerie moléculaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Hôtel-Dieu de Québec

Québec, Canada

Location

Related Publications (3)

• Vallabhajosula S, Nikolopoulou A, Babich JW, Osborne JR, Tagawa ST, Lipai I, Solnes L, Maresca KP, Armor T, Joyal JL, Crummet R, Stubbs JB, Goldsmith SJ. 99mTc-labeled small-molecule inhibitors of prostate-specific membrane antigen: pharmacokinetics and biodistribution studies in healthy subjects and patients with metastatic prostate cancer. J Nucl Med. 2014 Nov;55(11):1791-8. doi: 10.2967/jnumed.114.140426. Epub 2014 Oct 23.

  PMID: 25342385 BACKGROUND

• Eder M, Eisenhut M, Babich J, Haberkorn U. PSMA as a target for radiolabelled small molecules. Eur J Nucl Med Mol Imaging. 2013 Jun;40(6):819-23. doi: 10.1007/s00259-013-2374-2. No abstract available.

  PMID: 23463331 BACKGROUND

• Hillier SM, Maresca KP, Lu G, Merkin RD, Marquis JC, Zimmerman CN, Eckelman WC, Joyal JL, Babich JW. 99mTc-labeled small-molecule inhibitors of prostate-specific membrane antigen for molecular imaging of prostate cancer. J Nucl Med. 2013 Aug;54(8):1369-76. doi: 10.2967/jnumed.112.116624. Epub 2013 Jun 3.

  PMID: 23733925 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

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); lortalamine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Ellis, MD

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 25, 2015
• Study Start: December 1, 2015
• Primary Completion: December 28, 2017
• Study Completion: December 28, 2017
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CA (12); US (33)