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.
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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...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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