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

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02615067

Run by

Molecular Insight Pharmaceuticals, Inc.

People needed

531

Starts

2015-12-01

Expected to finish

2017-12-28

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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