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

• Status: Completed
• Trial end date: 2017-12-28
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.

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).