Prostate Cancer Clinical Trial

INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers

Summary

The purpose of this study is to plan for future clinical trials in patients with metastatic urological cancers. Diluted iodinated contrast will be injected intra-tumorally under CT fluoroscopy guidance into bone, lymph node, soft tissue and liver metastases in subjects with metastatic prostate cancer, urothelial carcinoma, or renal cell carcinoma. 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 expression of the receptor CD155.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of adenocarcinoma of the prostate, renal cell carcinoma or urothelial carcinoma. Small cell or neuroendocrine tumors of the prostate are also permitted.
Radiographic evidence of at least one bone, lymph node, soft tissue, or liver metastasis, that is amenable to iodinated contrast injection, as judged by the study radiologist

Adequate laboratory values:

Platelets ≥ 100,000
INR ≤ 1.3
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

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).
Cr >2.0
History of iodinated contrast allergy
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)
Any other contraindication to CT with iodinated contrast, as CT with contrast will be used in the study.

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

10

Study ID:

NCT03071328

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

10

Study ID:

NCT03071328

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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