A Phase 2 Diagnostic Imaging Study With 99mTc-MIP-1404 in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | December 2013 |
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
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.
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.
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.
We found this trial at
11
sites
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials