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

Study Overview
=================
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.

Official Title
-----------------
A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Drug: 99mTc-MIP-1404


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: 99mTc-MIP-1404<br>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 | Drug: Drug: 99mTc-MIP-1404<br>* A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404<br>* Other names: MIP-1404;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland. | 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. | Within 3-6 hours of dosing SPECT/CT images will be taken | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes | 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. | Within 3-6 hours of dosing SPECT/CT images will be taken | 
| Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland | 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. | Within 3-6 hours of dosing SPECT/CT images will be taken | 
| Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions | 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. | Within 3-6 hours of dosing SPECT/CT images will be taken | 
| Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland. | 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. | Within 3-6 hours of dosing SPECT/CT images will be taken | 
| Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes. | 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. | Within 3-6 hours of dosing SPECT/CT images will be taken | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PROSTATE CANCER, HIGH-RISK, PROSTATECTOMY SURGERY, NEWLY DIAGNOSED