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

StatusRecruiting
PhasePhase 2
Started2023-12-27
View on ClinicalTrials.gov ↗

Amendment history

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.

The 50 most recent of 129 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-10-06
Eligibility criteria-4 characters
Inclusion Criteria: * PRE-REGISTRATION ELIGIBILITY * Patients must have metastatic prostate cancer with neuroendo [...] rentiation, as determined by at least one of the following: Histologically confirmed small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy. * Histologically confirmed small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy. Neuroendocrine prostate cancer includes mixed small cell wit [...] euroendocrine markers (e.g., chromogranin or synaptophysin) * Prostate adenocarcinoma with molecular features of neuroendo [...] cancer (e.g., 2 of the follow [...]
Secondary endpointsdetails revised at 1 of 3 entries
Study sitesdetails revised at 5 of 13 sites
2026-07-11
2 amendments v127-v128
2 re-verifications since 2026-07-02, no change to tracked fields
2026-06-24
Study Status, Study Description, Conditions, Study Design, Outcome Measures, Contacts/Locations v126
Enrollment increased: 30 → 35 participants
Secondary endpointsdetails revised at 1 of 3 entries
Study description+6 characters
[...] utetium Lu 177 dotatate and then every 3 months for 2 years afteruntil removaldocumented fromdisease studyprogression or until death, whichever occurs first.
Study sites13 entries, revised
MUT DMD Anderson Cancer Center
2026-05-23
Study Status, Contacts/Locations v125
Study sitesdetails revised at 2 of 13 sites
2026-05-14
Study Status, Contacts/Locations v124
Study sitesdetails revised at 1 of 13 sites
Show 44 earlier versions
2026-05-12
Study Status, Arms and Interventions v123
Re-verified, no change to tracked fields
2026-04-29
Study Status, Contacts/Locations v122
Study sitesdetails revised at 1 of 13 sites
2026-04-09
42 amendments v80-v121
42 re-verifications since 2026-02-10, no change to tracked fields
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 drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Treatment with Lutetium Lu 177 dotatate may shrink the tumor in a way that can be measured in patients with metastatic prostate cancer with neuroendocrine differentiation.
Trial Details
NCT Number NCT05691465
Lead Sponsor National Cancer Institute (NCI)
Conditions Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Neuroendocrine Carcinoma, Metastatic Prostate Small Cell Neuroendocrine Carcinoma, Stage IVB Prostate Cancer AJCC v8
Enrollment 35 participants
Start Date 2023-12-27
Primary Completion 2026-11-02 (estimated)
Study Completion 2026-11-02 (estimated)
Updated on ClinicalTrials.gov 2026-10-07