A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology

Phase 2

Completed

Conditions: Prostate Cancer

Registration Number: NCT01667536

Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.

Brief Summary: This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.

Detailed Description: This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 105

Inclusion Criteria

Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Biopsy confirmed presence of adenocarcinoma of the prostate gland.
At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130.
Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection.

Exclusion Criteria

Participating would significantly delay the scheduled standard of care therapy.
Administered a radioisotope within 5 physical half lives prior to study drug injection.
Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
Have a contraindication for MR imaging.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.	Within 3-6 hours of dosing SPECT/CT images will be taken	For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.

Secondary Outcome Measures

Name	Time	Method
Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes	Within 3-6 hours of dosing SPECT/CT images will be taken	For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.	Within 3-6 hours of dosing SPECT/CT images will be taken	Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.
Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland	Within 3-6 hours of dosing SPECT/CT images will be taken	For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.
Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions	Within 3-6 hours of dosing SPECT/CT images will be taken	For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.	Within 3-6 hours of dosing SPECT/CT images will be taken	Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.

Trial Locations

Locations (34): City of Hope National Cancer Center
🇺🇸
Duarte, California, United States
Mayo Clinic
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Rochester, Minnesota, United States
New York Presbyterian Hospital - Cornell
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New York City, New York, United States
Duke University Medical Center
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Durham, North Carolina, United States
Glickman Urology & Kidney Institute, Cleveland Clinic
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Cleveland, Ohio, United States
Thomas Jefferson University / Jefferson Urology Associates
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Philadelphia, Pennsylvania, United States
Medical University of South Carolina
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Charleston, South Carolina, United States
University of Texas Vanguard Urologic Research Foundation
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Houston, Texas, United States
University of Washington School of Medicine
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Seattle, Washington, United States
University of Wisconsin
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Madison, Wisconsin, United States
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City of Hope National Cancer Center
🇺🇸Duarte, California, United States