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

NCT ID: NCT02615067

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 531 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

99mTc-MIP-1404 Injection

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

Group Type: EXPERIMENTAL

99mTc-MIP-1404 Injection

Intervention Type: DRUG

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

Whole-Body Planar and pelvic SPECT/CT scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

99mTc-MIP-1404 Injection

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

Intervention Type: DRUG

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

1404

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Molecular Insight Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Ellis, MD

Role: STUDY_CHAIR

University of Washington

Locations

City of Hope Cancer Center

Duarte, California, United States

VA Greater Los Angeles Healthcare

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Urology Partners - Tampa Bay

Clearwater, Florida, United States

Morton Plant Hospital

Clearwater, Florida, United States

University of Georgia / Regents Medical Center

Augusta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Louisiana State University Health Science Center

Shreveport, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Montgomery General Hospital

Olney, Maryland, United States

Lahey Clinic

Burlington, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Cooper Health System

Camden, New Jersey, United States

Weill Cornell Medical College

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Northeast Urology Research

Concord, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Urologic Consultants of Southeastern PA, LLP

Bala-Cynwyd, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Rockledge, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Washington School of Medicine

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Prostate Cancer Centre

Calgary, AB, Alberta, Canada

Lions Gate Hospital

North Vancouver, British Columbia, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Cancer Care Nova Scotia

Halifax, Nova Scotia, Canada

Ottawa Hospital Research Institute, University of Ottawa

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

MUHC

Montreal, Quebec, Canada

Centre d'imagerie moléculaire de Sherbrooke

Sherbrooke, Quebec, Canada

Hôtel-Dieu de Québec

Québec, , Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 25342385 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23463331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23733925 (View on PubMed)

Other Identifiers

MIP-1404-3301

Identifier Type: -

Identifier Source: org_study_id