Clinical trial NCT02615067: Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Diagnostic
Active surveillance
Very low risk
Imaging
PSMA
SPECT/CT
99mTc
Newly Diagnosed
Prostatectomy
Biopsy
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 531
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: Specificity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]
timeFrame: Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
measure: Sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]
timeFrame: Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Secondary outcomes:
measure: Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]
timeFrame: Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
measure: Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]
timeFrame: Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
measure: Clinical safety of 99mTc-MIP-1404
timeFrame: Changes in vital signs and clinical laboratory test results from time of screening until pre-surgery (Day 0 - 42). Treatment-emergent adverse events from study drug injection until pre-surgery or pre-biopsy (within 42 days)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Cancer Center
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Clearwater
country: United States
facility: Florida Urology Partners - Tampa Bay
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Augusta
country: United States
facility: University of Georgia / Regents Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Olney
country: United States
facility: Montgomery General Hospital
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern PA, LLP
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Rockledge
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Calgary, AB
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Cancer Care Nova Scotia
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute, University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: MUHC
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre d'imagerie moléculaire de Sherbrooke
state: Quebec
city: Québec
country: Canada
facility: Hôtel-Dieu de Québec
Study officials:
affiliation: University of Washington
name: William Ellis, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.