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


Condition: Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Urothelial Carcinoma, Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03071328

Sponsor: Duke University

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. 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.
  2. 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
  3. Adequate laboratory values:
  4. Platelets ≥ 100,000
  5. INR ≤ 1.3
  6. Age > 18 years.
  7. 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.

View trial on ClinicalTrials.gov