search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
99mTc-MIP-1404 Injection
Whole-Body Planar and pelvic SPECT/CT scan
Sponsored by
Molecular Insight Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Diagnostic, Active surveillance, Very low risk, Imaging, PSMA, SPECT/CT, 99mTc, Newly Diagnosed, Prostatectomy, Biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • City of Hope Cancer Center
  • VA Greater Los Angeles Healthcare
  • University of California, Los Angeles
  • University of California San Francisco
  • University of Colorado Cancer Center
  • Yale Cancer Center
  • Florida Urology Partners - Tampa Bay
  • Morton Plant Hospital
  • University of Georgia / Regents Medical Center
  • University of Chicago
  • Louisiana State University Health Science Center
  • Johns Hopkins University
  • Montgomery General Hospital
  • Lahey Clinic
  • University of Michigan
  • University of Minnesota
  • Mayo Clinic
  • Washington University
  • Cooper Health System
  • Weill Cornell Medical College
  • Stony Brook University Medical Center
  • Northeast Urology Research
  • Duke University Medical Center
  • Cleveland Clinic
  • University of Oklahoma Peggy and Charles Stephenson Cancer Center
  • Urologic Consultants of Southeastern PA, LLP
  • University of Pennsylvania
  • Thomas Jefferson University
  • Fox Chase Cancer Center
  • Medical University of South Carolina
  • Virginia Mason Medical Center
  • University of Washington School of Medicine
  • University of Wisconsin
  • Prostate Cancer Centre
  • Lions Gate Hospital
  • Cancer Care Manitoba
  • Cancer Care Nova Scotia
  • Ottawa Hospital Research Institute, University of Ottawa
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Cancer Centre
  • Centre hospitalier de l'Université de Montréal (CHUM)
  • Jewish General Hospital
  • MUHC
  • Centre d'imagerie moléculaire de Sherbrooke
  • Hôtel-Dieu de Québec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

99mTc-MIP-1404 Injection

Arm Description

20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
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)
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.

Full Information

First Posted
November 20, 2015
Last Updated
April 4, 2019
Sponsor
Molecular Insight Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02615067
Brief Title
Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
December 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecular Insight Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Diagnostic, Active surveillance, Very low risk, Imaging, PSMA, SPECT/CT, 99mTc, Newly Diagnosed, Prostatectomy, Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
531 (Actual)

8. Arms, Groups, and Interventions

Arm Title
99mTc-MIP-1404 Injection
Arm Type
Experimental
Arm Description
20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404
Intervention Type
Drug
Intervention Name(s)
99mTc-MIP-1404 Injection
Other Intervention Name(s)
1404
Intervention Description
A single dose of 20 (±3) mCi intravenous (IV) injection of 99mTc-MIP-1404.
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole-Body Planar and pelvic SPECT/CT scan
Intervention Description
A whole-body planar and pelvic SPECT/CT scan will be obtained 3-6 hours after injection of 99mTc-MIP-1404.
Primary Outcome Measure Information:
Title
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]
Description
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.
Time Frame
Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Title
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]
Description
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.
Time Frame
Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Secondary Outcome Measure Information:
Title
Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]
Description
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)
Time Frame
Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Title
Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]
Description
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)
Time Frame
Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken
Title
Clinical safety of 99mTc-MIP-1404
Description
Clinical laboratory tests will include hematology and clinical chemistry. Vital signs will include heart rate, blood pressure, temperature and respiration rate.
Time Frame
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Ellis, MD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
VA Greater Los Angeles Healthcare
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Florida Urology Partners - Tampa Bay
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University of Georgia / Regents Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Louisiana State University Health Science Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Montgomery General Hospital
City
Olney
State/Province
Maryland
ZIP/Postal Code
20832
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Northeast Urology Research
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Oklahoma Peggy and Charles Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Urologic Consultants of Southeastern PA, LLP
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-2640
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Rockledge
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29435
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Prostate Cancer Centre
City
Calgary, AB
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Cancer Care Nova Scotia
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Ottawa Hospital Research Institute, University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
MUHC
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Centre d'imagerie moléculaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hôtel-Dieu de Québec
City
Québec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25342385
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.
Results Reference
background
PubMed Identifier
23463331
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.
Results Reference
background
PubMed Identifier
23733925
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs