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Tests treatment safety and results for Metastatic Prostate Adenocarcinoma With Neuroendocrine...
Official title Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
ClinicalTrials.gov ID: NCT05691465
What this study is testing
What is Lutetium Lu 177 Dotatate?
Lutetium Lu 177 Dotatate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic prostate adenocarcinoma with neuroendocrine differentiation.
Also referred to as 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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)
- Progression of visceral metastases in the absence of PSA progression
You likely can't join if
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lutetium Lu 177 dotatate
- As per the Food and Drug Administration (FDA) package insert for Lutetium Lu 177 dotatate, use of long-acting somatostatin analogs (e.g., long-acting...
- Patients with uncontrolled intercurrent illness
- Any of the following within 6 months before starting treatment: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral...
- Uncontrolled hypertension as indicated by a systolic blood pressure \>= 160 mmHg or diastolic blood pressure \>= 100 mmHg at screening
See the full 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 mixed small cell with adenocarcinoma histology, as well as small or...
- Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss)
- Progression of visceral metastases in the absence of PSA progression
- Serum chromogranin A \> 5x normal limit, or neuron-specific enolase \> 2x normal NOTE: Both patients who have had prior cytotoxic chemotherapy and patients who have never had cytotoxic chemotherapy for prostate cancer...
- Age \>= 18 years. Prostate cancer is typically a disease of older men, with the average age at diagnosis being 65 years. Consequently, because the research topic is not relevant to children, no children will be included...
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%)
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>= 8 g/dL, prior to each dose of lutetium lu 177 dotatate
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x institutional ULN
- Creatinine Cockcroft calculated creatinine clearance of \>= 40 mL/min
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients should be New York Heart Association Functional Classification of class 2B or better
- Current disease progression according to PCWG3 criteria
- Ongoing use of luteinizing hormone-releasing hormone (LHRH) agonists/antagonists will be required (unless prior bilateral orchiectomy or pure neuroendocrine carcinoma histology) to maintain testosterone at castrate...
- No concurrent use of other anti-cancer therapies
- Pregnancy Precaution: The effects of lutetium lu 177 dotatate on the developing human fetus are unknown. For this reason and because radionuclides are known to be teratogenic, male participants and their female partners...
- Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member...
- Patients will undergo a Gallium 68 Dotatate PET scan after enrollment. The Gallium 68 Dotatate PET must be positive to proceed with lutetium Lu 177 dotatate therapy. A positive scan will be defined as at least one...
- REGISTRATION ELIGIBILITY: The gallium 68 dotatate PET is positive. A positive scan will be defined as at least one lesion with an maximum standardized uptake value (SUVmax) \> the average SUV of normal liver. The...
- REGISTRATION ELIGIBILITY: Absolute neutrophil count ≥ 1,500/mcL
- REGISTRATION ELIGIBILITY: Platelets ≥ 100,000/mcL
- REGISTRATION ELIGIBILITY: Hemoglobin ≥ 8 g/dL, prior to each dose of lutetium Lu 177 dotatate
- REGISTRATION ELIGIBILITY: Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
- REGISTRATION ELIGIBILITY: AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- REGISTRATION ELIGIBILITY: Creatinine Cockcroft calculated creatinine clearance of ≥ 40 mL/min OR
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lutetium Lu 177 dotatate
- As per the Food and Drug Administration (FDA) package insert for Lutetium Lu 177 dotatate, use of long-acting somatostatin analogs (e.g., long-acting octreotide) is prohibited within 4 weeks prior to initiating Lutetium...
- Patients with uncontrolled intercurrent illness
- Any of the following within 6 months before starting treatment: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart...
- Uncontrolled hypertension as indicated by a systolic blood pressure \>= 160 mmHg or diastolic blood pressure \>= 100 mmHg at screening
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Chicago, Illinois, United States; Lexington, Kentucky, United States; Baltimore, Maryland, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.