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

April 4, 2019 updated by: Molecular Insight Pharmaceuticals, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

531

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
Time Frame: 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.
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]
Time Frame: 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.
Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]
Time Frame: 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)
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]
Time Frame: 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)
Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Clinical safety of 99mTc-MIP-1404
Time Frame: 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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molecular Insight Pharmaceuticals, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIP-1404-3301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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