OncoMatch/Clinical Trials/NCT05691465
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
Is NCT05691465 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Lutetium Lu 177 Dotatate for metastatic prostate adenocarcinoma with neuroendocrine differentiation.
Treatment: Lutetium Lu 177 Dotatate — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Cancer type
Prostate Cancer
Biomarker criteria
Allowed: PTEN loss
2 of the following 3: PTEN, TP53, or RB loss
Allowed: TP53 loss
2 of the following 3: PTEN, TP53, or RB loss
Allowed: RB1 loss
2 of the following 3: PTEN, TP53, or RB loss
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: other anti-cancer therapies
No concurrent use of other anti-cancer therapies
Cannot have received: investigational agents
Patients who are receiving any other investigational agents
Lab requirements
Blood counts
ANC >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin >= 8 g/dL
Kidney function
Creatinine Cockcroft calculated creatinine clearance of >= 40 mL/min
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST(SGOT)/ALT(SGPT) <= 3 x institutional ULN
Cardiac function
New York Heart Association Functional Classification of class 2B or better
Absolute neutrophil count (ANC) >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin >= 8 g/dL; Total bilirubin <= 1.5 x institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) <= 3 x institutional ULN; Creatinine Cockcroft calculated creatinine clearance of >= 40 mL/min; Patients should be New York Heart Association Functional Classification of class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- Northwestern University · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05691465 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior other anti-cancer therapies, investigational agents disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages