RECRUITING

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

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Conditions

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine CarcinomaMetastatic Prostate Small Cell Neuroendocrine CarcinomaStage IV Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer With Neuroendocrine Differentiation

Quick Facts

Study Start:2023-12-27
Study Completion:2025-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05691465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRE-REGISTRATION ELIGIBILITY
  2. * Patients must have metastatic prostate cancer with neuroendocrine differentiation, as determined by at least one of the following:
  3. * 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 large cells with positive neuroendocrine markers (e.g., chromogranin or synaptophysin)
  4. * Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss)
  5. * Progression of visceral metastases in the absence of PSA progression
  6. * 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 will be allowed
  7. * 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 in this study. There is no upper limit to the age of participants eligible for this study
  8. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
  9. * Absolute neutrophil count (ANC) \>= 1,500/mcL
  10. * Platelets \>= 100,000/mcL
  11. * Hemoglobin \>= 8 g/dL, prior to each dose of lutetium lu 177 dotatate
  12. * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
  13. * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
  14. * Creatinine Cockcroft calculated creatinine clearance of \>= 40 mL/min
  15. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  16. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  17. * 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 load.
  18. * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  19. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  20. * Patients should be New York Heart Association Functional Classification of class 2B or better
  21. * Current disease progression according to PCWG3 criteria
  22. * 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 levels. Patients with a pure neuroendocrine carcinoma histology do not need to be undergoing LHRH agonist/antagonist therapy
  23. * No concurrent use of other anti-cancer therapies
  24. * 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 must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lutetium lu 177 dotatate administration. Patients must not donate sperm during the study and for 3 months after the last study drug administration
  25. * 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 available will also be eligible
  26. * 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 lesion with an maximum standardized uptake value (SUVmax) \> the average standardized uptake value (SUV) of normal liver. The positive lesion(s) can be in any location (bone metastases or visceral metastases). Patients with only bone metastases will be allowed
  27. * 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 positive lesion(s) can be in any location (bone metastases or visceral metastases). Patients with only bone metastases will be allowed.
  28. * REGISTRATION ELIGIBILITY: Absolute neutrophil count ≥ 1,500/mcL
  29. * REGISTRATION ELIGIBILITY: Platelets ≥ 100,000/mcL
  30. * REGISTRATION ELIGIBILITY: Hemoglobin ≥ 8 g/dL, prior to each dose of lutetium Lu 177 dotatate
  31. * REGISTRATION ELIGIBILITY: Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
  32. * REGISTRATION ELIGIBILITY: AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
  33. * REGISTRATION ELIGIBILITY: Creatinine Cockcroft calculated creatinine clearance of ≥ 60 mL/min OR
  34. * REGISTRATION ELIGIBILITY: Glomerular filtration rate (GFR) of 60 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2
  1. * Patients who are receiving any other investigational agents
  2. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lutetium Lu 177 dotatate
  3. * 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 Lu 177 dotatate and during treatment. Use of short-acting somatostatin analogs is prohibited within 24 hours prior to initiating Lutetium Lu 177 dotatate and during treatment. Long-acting somatostatin analogs or short-acting somatostatin analogs will be allowed if the patient has a history of carcinoid syndrome and requires long-acting or short-acting somatostatin analogs for the control of his functional syndrome
  4. * Patients with uncontrolled intercurrent illness
  5. * 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 Association (NYHA) Class III or IV
  6. * Uncontrolled hypertension as indicated by a systolic blood pressure \>= 160 mmHg or diastolic blood pressure \>= 100 mmHg at screening

Contacts and Locations

Principal Investigator

John M Floberg
PRINCIPAL_INVESTIGATOR
JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Locations (Sites)

City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Los Angeles General Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Baltimore, Maryland, 21231
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • John M Floberg, PRINCIPAL_INVESTIGATOR, JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-27
Study Completion Date2025-11-01

Study Record Updates

Study Start Date2023-12-27
Study Completion Date2025-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation
  • Metastatic Prostate Neuroendocrine Carcinoma
  • Metastatic Prostate Small Cell Neuroendocrine Carcinoma
  • Stage IV Prostate Cancer AJCC v8