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

Prostate Cancer Clinical Trial

— proSPECT-AS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615067
• Other study ID #: MIP-1404-3301
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: December 28, 2017

Study information

• Verified date: April 2019
• Source: Molecular Insight Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 531
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 a-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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 99mTc-MIP-1404 Injection
A single dose of 20 (±3) mCi intravenous (IV) injection of 99mTc-MIP-1404.

Diagnostic Test:
• Whole-Body Planar and pelvic SPECT/CT scan
A whole-body planar and pelvic SPECT/CT scan will be obtained 3-6 hours after injection of 99mTc-MIP-1404.

Locations

Country	Name	City	State
Canada	Prostate Cancer Centre	Calgary, AB	Alberta
Canada	Cancer Care Nova Scotia	Halifax	Nova Scotia
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec
Canada	Jewish General Hospital	Montréal	Quebec
Canada	MUHC	Montréal	Quebec
Canada	Lions Gate Hospital	North Vancouver	British Columbia
Canada	Ottawa Hospital Research Institute, University of Ottawa	Ottawa	Ontario
Canada	Hôtel-Dieu de Québec	Québec
Canada	Centre d'imagerie moléculaire de Sherbrooke	Sherbrooke	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Georgia / Regents Medical Center	Augusta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Urologic Consultants of Southeastern PA, LLP	Bala-Cynwyd	Pennsylvania
United States	Johns Hopkins University	Baltimore	Maryland
United States	Lahey Clinic	Burlington	Massachusetts
United States	Cooper Health System	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Florida Urology Partners - Tampa Bay	Clearwater	Florida
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Northeast Urology Research	Concord	North Carolina
United States	City of Hope Cancer Center	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California, Los Angeles	Los Angeles	California
United States	VA Greater Los Angeles Healthcare	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale Cancer Center	New Haven	Connecticut
United States	Weill Cornell Medical College	New York	New York
United States	University of Oklahoma Peggy and Charles Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Montgomery General Hospital	Olney	Maryland
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Fox Chase Cancer Center	Rockledge	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	University of California San Francisco	San Francisco	California
United States	University of Washington School of Medicine	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Louisiana State University Health Science Center	Shreveport	Louisiana
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Molecular Insight Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes, if applicable, (as determined by histopathology) in patients undergoing RP (with or without extended pelvic lymph node dissection) or routine prostate biopsy. Pathology results will be used as the truth standard for all imaging analyses.	Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Primary	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]	Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes (as determined by histopathology) in patients undergoing standard of care prostatectomy with or without extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.	Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Secondary	Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]	Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)	Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Secondary	Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]	Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)	Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Secondary	Clinical safety of 99mTc-MIP-1404	Clinical laboratory tests will include hematology and clinical chemistry. Vital signs will include heart rate, blood pressure, temperature and respiration rate.	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)