Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
a study on Prostate Cancer
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.
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)
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.
Prostate Cancer Diagnostic Active surveillance Very low risk Imaging PSMA SPECT/CT 99mTc Newly Diagnosed Prostatectomy Biopsy
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...
- 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).
- University of California San Francisco accepting new patients
San Francisco, California, 94143, United States
- 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
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02615067.