Clincosm LogoSign in Get a demo

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

Sponsor
Molecular Insight Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02615067
Collaborator
(none)
531
Enrollment
45
Locations
1
Arm
24.9
Duration (Months)
11.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 99mTc-MIP-1404 Injection
  • Diagnostic Test: Whole-Body Planar and pelvic SPECT/CT scan
 Phase 3

Detailed Description

This is a multi-center, multi-reader, open-label trial, comparing 99mTc-MIP-1404 SPECT/CT imaging in men who have had a diagnostic trans-rectal ultrasound (TRUS) guided biopsy with a histopathologic finding of Gleason score ≤3+4 who are candidates for active surveillance and are undergoing routine biopsy or voluntary RP with or without a pelvic lymph node dissection (PLND). This study will evaluate the sensitivity and specificity of 99mTc-MIP-1404 SPECT/CT image assessments to correctly identify subjects with previously unknown clinically significant prostate cancer in two cohorts: (1) Low grade prostate cancer who have elected to undergo RP [Cohort A]; and (2) very low risk (VLR) prostate cancer per 2016 NCCN Guidelines who are scheduled to undergo routine prostate biopsy [Cohort B].

Subjects will receive a single dose of 99mTc-MIP-1404 Injection (study drug) followed by whole body planar and SPECT/CT (pelvic) imaging 3-6 hours after injection. In accordance with standard of care procedures, subjects will undergo either voluntary RP [Cohort A] or prostate biopsy [Cohort B] within 42 days after study drug dosing. 99mTc-MIP-1404 image data will be collected by a central imaging core laboratory and evaluated for visible uptake within the prostate gland. These findings will then be compared against central histopathology as the truth standard. The central imaging core lab independent readers for the SPECT/CT scans will be blinded to all clinical data, including pathology results. Likewise, central pathologists are to remain blinded to all clinical data, including imaging results.

Study Design

Study Type:
Interventional
Actual Enrollment :
531 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance (proSPECT-AS)
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Dec 28, 2017
Actual Study Completion Date :
Dec 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 99mTc-MIP-1404 Injection

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

Drug: 99mTc-MIP-1404 Injection
A single dose of 20 (±3) mCi intravenous (IV) injection of 99mTc-MIP-1404.
Other Names:
  • 1404

    • Diagnostic Test: Whole-Body Planar and pelvic SPECT/CT scan
    A whole-body planar and pelvic SPECT/CT scan will be obtained 3-6 hours after injection of 99mTc-MIP-1404.

    Outcome Measures

    Primary Outcome Measures

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

      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.

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

      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.

    Secondary Outcome Measures

    1. 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]

      Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)

    2. 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]

      Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)

    3. 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)]

      Clinical laboratory tests will include hematology and clinical chemistry. Vital signs will include heart rate, blood pressure, temperature and respiration rate.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    INCLUSION CRITERIA:

    • 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

    EXCLUSION CRITERIA:

    1. Subjects administered a radioisotope within 5 physical half-lives prior to study drug injection.

    2. 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)

    3. Planned androgen or anti-androgen therapy prior to RP surgery or biopsy

    4. 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

    5. 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Cancer Center Duarte California United States 91010
    2 VA Greater Los Angeles Healthcare Los Angeles California United States 90073
    3 University of California, Los Angeles Los Angeles California United States 90095
    4 University of California San Francisco San Francisco California United States 94143
    5 University of Colorado Cancer Center Aurora Colorado United States 80045
    6 Yale Cancer Center New Haven Connecticut United States 06520
    7 Florida Urology Partners - Tampa Bay Clearwater Florida United States 33612
    8 Morton Plant Hospital Clearwater Florida United States 33765
    9 University of Georgia / Regents Medical Center Augusta Georgia United States 30912
    10 University of Chicago Chicago Illinois United States 60637
    11 Louisiana State University Health Science Center Shreveport Louisiana United States 71103
    12 Johns Hopkins University Baltimore Maryland United States 21205
    13 Montgomery General Hospital Olney Maryland United States 20832
    14 Lahey Clinic Burlington Massachusetts United States 01805
    15 University of Michigan Ann Arbor Michigan United States 48109
    16 University of Minnesota Minneapolis Minnesota United States 55455
    17 Mayo Clinic Rochester Minnesota United States 55905
    18 Washington University Saint Louis Missouri United States 63110
    19 Cooper Health System Camden New Jersey United States 08103
    20 Weill Cornell Medical College New York New York United States 10065
    21 Stony Brook University Medical Center Stony Brook New York United States 11794
    22 Northeast Urology Research Concord North Carolina United States 28025
    23 Duke University Medical Center Durham North Carolina United States 27710
    24 Cleveland Clinic Cleveland Ohio United States 44195
    25 University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    26 Urologic Consultants of Southeastern PA, LLP Bala-Cynwyd Pennsylvania United States 19004
    27 University of Pennsylvania Philadelphia Pennsylvania United States 19104-2640
    28 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    29 Fox Chase Cancer Center Rockledge Pennsylvania United States 19046
    30 Medical University of South Carolina Charleston South Carolina United States 29435
    31 Virginia Mason Medical Center Seattle Washington United States 98101
    32 University of Washington School of Medicine Seattle Washington United States 98109
    33 University of Wisconsin Madison Wisconsin United States 53792
    34 Prostate Cancer Centre Calgary, AB Alberta Canada T2V 1P9
    35 Lions Gate Hospital North Vancouver British Columbia Canada V7L 2L7
    36 Cancer Care Manitoba Winnipeg Manitoba Canada R3E 0V9
    37 Cancer Care Nova Scotia Halifax Nova Scotia Canada B3H 2Y9
    38 Ottawa Hospital Research Institute, University of Ottawa Ottawa Ontario Canada K1H 8L6
    39 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    40 Princess Margaret Cancer Centre Toronto Ontario Canada
    41 Centre hospitalier de l'Université de Montréal (CHUM) Montréal Quebec Canada H2X 0A9
    42 Jewish General Hospital Montréal Quebec Canada H3T 1E2
    43 MUHC Montréal Quebec Canada H4A 3J1
    44 Centre d'imagerie moléculaire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4
    45 Hôtel-Dieu de Québec Québec Canada

    Sponsors and Collaborators

    • Molecular Insight Pharmaceuticals, Inc.

    Investigators

    • Study Chair: William Ellis, MD, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Molecular Insight Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02615067
    Other Study ID Numbers:
    • MIP-1404-3301
    First Posted:
    Nov 25, 2015
    Last Update Posted:
    Apr 10, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Molecular Insight Pharmaceuticals, Inc.
    Diagnostic
    Active surveillance
    Very low risk
    Imaging
    PSMA
    SPECT/CT
    99mTc
    Newly Diagnosed
    Prostatectomy
    Biopsy
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Apr 10, 2019