Trial Title:
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
NCT ID:
NCT05691465
Condition:
Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation
Metastatic Prostate Neuroendocrine Carcinoma
Metastatic Prostate Small Cell Neuroendocrine Carcinoma
Stage IV Prostate Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma, Small Cell
Lutetium Lu 177 dotatate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood
Arm group label:
Treatment (lutetium Lu 177 dotatate)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (lutetium Lu 177 dotatate)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
Gallium Ga 68-DOTATATE
Description:
Given IV
Arm group label:
Treatment (lutetium Lu 177 dotatate)
Other name:
(68)Ga-DOTA-TATE
Other name:
68Ga-DOTA-0-Tyr3-Octreotate
Other name:
68Ga-DOTATATE
Other name:
Gallium Ga 68 Oxodotreotide
Other name:
Gallium Oxodotreotide Ga-68
Other name:
Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Intervention type:
Drug
Intervention name:
Lutetium Lu 177 Dotatate
Description:
Given IV
Arm group label:
Treatment (lutetium Lu 177 dotatate)
Other name:
177 Lu-DOTA-TATE
Other name:
177 Lu-DOTA-Tyr3-Octreotate
Other name:
177Lu-DOTA0-Tyr3-Octreotate
Other name:
Lutathera
Other name:
Lutetium (177Lu) Oxodotreotide
Other name:
Lutetium Lu 177 DOTA(0)-Tyr(3)-Octreotate
Other name:
Lutetium Lu 177-DOTA-Tyr3-Octreotate
Other name:
lutetium Lu 177-DOTATATE
Other name:
Lutetium Oxodotreotide Lu-177
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Treatment (lutetium Lu 177 dotatate)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Summary:
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-dotate 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.
Detailed description:
PRIMARY OBJECTIVE:
I. Evaluate the objective response rate for patients treated with lutetium Lu 177
dotatate using Prostate Cancer Working Group (PCWG) 3 criteria.
SECONDAY OBJECTIVES:
I. Evaluate the 6-month radiographic progression-free survival of
neuroendocrine-differentiated prostate cancer treated with lutetium Lu 177 dotatate.
II. Determine if the change in fludeoxyglucose (FDG)-positron emission tomography (PET)
signal from pre-treatment to after 2 doses of lutetium Lu 177 dotatate correlates with
objective response rate.
EXPLORATORY OBJECTIVES:
I. Evaluate the potential to perform patient-specific dosimetry of lutetium Lu 177
dotatate using gamma imaging to predict treatment response and renal toxicity.
II. Perform gene expression analysis of circulating tumor cells to identify pre-treatment
biomarkers of response and signatures of resistance at the time of progression.
OUTLINE:
Patients receive lutetium Lu 177 dotatate intravenously (IV) over 30 minutes. Cycles
repeat every 6 weeks (Q6W) for up to 4 cycles in the absence of disease progression or
unacceptable toxicity. Patients also receive gallium Ga 68-dotatate IV during screening
then undergo positron emission tomography (PET)/computed tomography (CT) scan at baseline
and collection of blood throughout the trial.
Patients are followed up at 6 weeks after last dose lutetium Lu 177 dotatate and then
every 3 months for 2 years after removal from study or until death, whichever occurs
first.
Criteria for eligibility:
Criteria:
Inclusion 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 large cells with
positive neuroendocrine markers (e.g., chromogranin or synaptophysin)
- 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
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 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 >= 60 mL/min OR
- 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
- 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 load.
- 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 efficacy assessment of
the investigational regimen are eligible for this trial
- 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 levels. Patients with a
pure neuroendocrine carcinoma histology do not need to be undergoing LHRH
agonist/antagonist therapy
- 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 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
- 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
- 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
- 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.
- 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 ≥
60 mL/min OR
- 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
Exclusion Criteria:
- 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 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
- 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 Association (NYHA) Class III or IV
- Uncontrolled hypertension as indicated by a systolic blood pressure >= 160 mmHg or
diastolic blood pressure >= 100 mmHg at screening
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Comprehensive Cancer Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-826-4673
Email:
becomingapatient@coh.org
Investigator:
Last name:
Abhishek Tripathi
Email:
Principal Investigator
Facility:
Name:
Los Angeles General Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Email:
uscnorrisinfo@med.usc.edu
Investigator:
Last name:
Jacek Pinski
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Investigator:
Last name:
Jacek Pinski
Email:
Principal Investigator
Facility:
Name:
University of California Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
916-734-3089
Investigator:
Last name:
Mamta Parikh
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
Maha H. Hussain
Email:
Principal Investigator
Facility:
Name:
University of Kentucky/Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Zin W. Myint
Phone:
859-323-3964
Email:
zin.myint@uky.edu
Investigator:
Last name:
Zin W. Myint
Email:
Principal Investigator
Facility:
Name:
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Contact:
Last name:
John M. Floberg
Phone:
608-262-6968
Email:
jfloberg@humonc.wisc.edu
Investigator:
Last name:
John M. Floberg
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University/Sidney Kimmel Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
410-955-8804
Email:
jhcccro@jhmi.edu
Investigator:
Last name:
Michael A. Carducci
Email:
Principal Investigator
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
336-713-6771
Investigator:
Last name:
Michael McCormack
Email:
Principal Investigator
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-293-5066
Email:
Jamesline@osumc.edu
Investigator:
Last name:
Edmund Folefac
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-632-6789
Email:
askmdanderson@mdanderson.org
Investigator:
Last name:
Ana Aparicio
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center - University Hospital
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-622-8922
Email:
clinicaltrials@cancer.wisc.edu
Investigator:
Last name:
John M. Floberg
Email:
Principal Investigator
Start date:
December 27, 2023
Completion date:
November 1, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05691465
