Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

This phase II trial studies how well lutetium Lu 177 dotatate works in treating patients with prostate cancer with neuroendocrine differentiation that has spread to other places in the body (metastatic). Neuroendocrine differentiation refers to cells that have traits of both hormone-producing endocrine cells and nerve cells. These cells release hormones into the blood in response to a signal from the nervous system. Hormones are biological substances that circulate through the bloodstream to control the activity of other organs or cells in the body. Lutetium Lu 177-dotatate is a radioactive dr

Trial Details

NCT ID
NCT05691465
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Neuroendocrine Prostate Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Gallium Ga 68-DOTATATE
  • Lutetium Lu 177 Dotatate
  • Positron Emission Tomography
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Sacramento, California, United States|38.58157,-121.4944
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • PRE-REGISTRATION ELIGIBILITY
  • Patients must have metastatic prostate cancer with neuroendocrine differentiation, as determined by at least one of the following:
  • Histologically confirmed small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy. Neuroendocrine prostate cancer includes …
  • Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss)

For full eligibility, visit ClinicalTrials.gov.

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