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Eligibility
for males ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

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)

Details

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.

Keywords

Prostate Cancer Diagnostic Active surveillance Very low risk Imaging PSMA SPECT/CT 99mTc Newly Diagnosed Prostatectomy Biopsy

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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 CAN'T join if...

  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).

Locations

  • City of Hope Cancer Center accepting new patients
    Duarte, California, 91010, United States
  • VA Greater Los Angeles Healthcare accepting new patients
    Los Angeles, California, 90073, United States
  • University of California, Los Angeles accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Molecular Insight Pharmaceuticals, Inc.
ID
NCT02615067
Phase
Phase 3
Lead Scientist
Hao Nguyen
Study Type
Interventional
Last Updated
April 1, 2017
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