INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Prostate Cancer
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | January 8, 2018 |
End Date: | August 31, 2019 |
Contact: | Julia Rasmussen, MS, RN, BSN |
Email: | julia.rasmussen@duke.edu |
Phone: | 919-681-1030 |
The purpose of this study is to plan for future clinical trials in patients with Metastatic
Castration-resistant Prostate Cancer (mCRPC). Diluted iodinated contrast will be injected
intra-tumorally under CT fluoroscopy guidance into bone, lymph node, and liver metastases in
subjects with mCRPC, and pre and post-injection CT images will be obtained to determine the
injection parameters needed for optimal distribution throughout metastases of a given size. A
biopsy of the metastatic site will also be obtained to validate the expression of CD155 in
prostate cancer.
Castration-resistant Prostate Cancer (mCRPC). Diluted iodinated contrast will be injected
intra-tumorally under CT fluoroscopy guidance into bone, lymph node, and liver metastases in
subjects with mCRPC, and pre and post-injection CT images will be obtained to determine the
injection parameters needed for optimal distribution throughout metastases of a given size. A
biopsy of the metastatic site will also be obtained to validate the expression of CD155 in
prostate cancer.
Inclusion Criteria:
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or
neuroendocrine tumors of the prostate are also permitted.
2. Radiographic evidence of at least one bone, lymph node, or liver metastasis, that is
amenable to iodinated contrast injection, as judged by the study radiologist
3. Adequate laboratory values:
1. Platelets ≥ 100,000
2. INR ≤ 1.3
4. Age > 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. History of intercurrent or past medical or psychiatric illness that would make
participation in a research biopsy protocol difficult or not feasible at the
discretion of the principal investigator or co-investigator(s).
2. Cr >2.0
3. History of iodinated contrast allergy
4. For patients undergoing research only biopsy: Requirement for anticoagulation with
heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban,
warfarin, Aggrenox, fondaparux, ticagrelor, etc (aspirin and other NSAIDs are ok but
should be held prior to biopsy in accordance with institutional standard of care)
5. Any other contraindication to CT with iodinated contrast, as CT with contrast will be
used in the study.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Megan McNamara, MD
Phone: 919-681-1030
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