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Prostate CancerPhase 3proSPECT-ASNCT02615067

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

A Phase 3 study testing 99mTc-MIP-1404 Injection and Whole-Body Planar and pelvic SPECT/CT scan in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 45 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
99mTc-MIP-1404 Injection and Whole-Body Planar and pelvic SPECT/CT scan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
531 participants
Where
45 sitesin 2 countries
Study dates
Dec 2015to 28 Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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).

Trial locations and contacts

45 sites in 2 countries.

45 sites in 2 countries

United States33 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Georgia / Regents Medical Center

    Augusta, Georgia, 30912

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Urologic Consultants of Southeastern PA, LLP

    Bala-Cynwyd, Pennsylvania, 19004

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Cooper Health System

    Camden, New Jersey, 08103

  • Medical University of South Carolina

    Charleston, South Carolina, 29435

  • University of Chicago

    Chicago, Illinois, 60637

  • Florida Urology Partners - Tampa Bay

    Clearwater, Florida, 33612

  • Morton Plant Hospital

    Clearwater, Florida, 33765

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Northeast Urology Research

    Concord, North Carolina, 28025

  • City of Hope Cancer Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • VA Greater Los Angeles Healthcare

    Los Angeles, California, 90073

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Montgomery General Hospital

    Olney, Maryland, 20832

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-2640

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Fox Chase Cancer Center

    Rockledge, Pennsylvania, 19046

  • University of California San Francisco

    San Francisco, California, 94143

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington School of Medicine

    Seattle, Washington, 98109

  • Louisiana State University Health Science Center

    Shreveport, Louisiana, 71103

  • Washington University

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

Other trials in United States

Canada12 sites

  • Prostate Cancer Centre

    Calgary, AB, Alberta, T2V 1P9

  • Cancer Care Nova Scotia

    Halifax, Nova Scotia, B3H 2Y9

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0A9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • MUHC

    Montreal, Quebec, H4A 3J1

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • Ottawa Hospital Research Institute, University of Ottawa

    Ottawa, Ontario, K1H 8L6

  • Hôtel-Dieu de Québec

    Québec

  • Centre d'imagerie moléculaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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)

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
99mTc-MIP-1404 Injection, Whole-Body Planar and pelvic SPECT/CT scan
Keywords
Diagnostic, Active surveillance, Very low risk, Imaging, PSMA, SPECT/CT, 99mTc, Newly Diagnosed, Prostatectomy, Biopsy
Medical subject headings
Prostatic Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 99mTc-MIP-1404 InjectionDrug

    Also called 1404

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

  • Whole-Body Planar and pelvic SPECT/CT scanDiagnostic test

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

Study groups in NCT02615067
Study groupRoleWhat they receive
99mTc-MIP-1404 InjectionExperimental20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404
Receives: Drug: 99mTc-MIP-1404 Injection; Diagnostic Test: Whole-Body Planar and pelvic SPECT/CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    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.

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

  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]

    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.

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

Secondary outcomes (3)

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

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

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

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

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

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

  3. Clinical safety of 99mTc-MIP-1404

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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completion28 Dec 2017
  4. Study completion28 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
531 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02615067
Sponsor's protocol ID
MIP-1404-3301
Acronym
proSPECT-AS
Status last verified
Apr 2019
First submitted
20 Nov 2015
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25342385

  • 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.

    PubMed 23463331

  • 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.

    PubMed 23733925

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 99mTc-MIP-1404 Injection and Whole-Body Planar and pelvic SPECT/CT scan in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 45 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615067, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.

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proSPECT-AS Clinical Trial NCT02615067 | AzTrials