177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT05204927
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
439 participants
INTERVENTIONAL
2022-02-14
2029-02-28
Brief Summary
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Detailed Description
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The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET imaging. Patients will be randomized at a ratio of 2:1 to receive either 177Lu-PSMA-I\&T or hormone therapy (abiraterone or enzalutamide) respectively. Patients randomized to the investigational product will receive up to 6 treatments every 6 weeks at a dose of 200 mCi (7.4 GBq). All patients will be followed for adverse events and safety labs throughout the course of the study. Progression of disease will be assessed radiographically using Prostate Working Group Criteria 3 (PWGC3) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of conventional imaging as well as PSA levels and symptom recording throughout the course of treatment.
30 patients will participate in a pharmacokinetic and radiation dosimetry sub-study at selected participating clinical sites. Sub-study participants will receive SPECT imaging after each treatment cycle for dosimetry analysis. Sub-study participants will not be randomized.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Standard Of Care Hormone Therapy
Abiraterone with Prednisone or Enzalutamide
Abiraterone with Prednisone or Enzalutamide
Hormone Therapy
Investigational Drug
177Lu-PSMA-I\&T
177Lu-PSMA-I&T
Radioligand therapy
Interventions
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177Lu-PSMA-I&T
Radioligand therapy
Abiraterone with Prednisone or Enzalutamide
Hormone Therapy
Eligibility Criteria
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Inclusion Criteria
2. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
3. Progressive disease by one or more of the following criteria:
1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of \>2 ng/mL.
2. Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria).
4. Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide).
1. Must have received no more than one previous AR-directed therapy.
2. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting.
3. Must have progressed while on ARAT.
5. PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader.
6. Effective castration with serum testosterone level of \<50 ng/dL and plan to continue with chronic medical or surgical castration.
7. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
8. Patients with HIV that are healthy and with a low risk of acquired immune deficiency syndrome related outcomes may participate in the trial at the investigators' discretion.
9. Patients with HBV and HCV may also participate if symptoms are sufficiently managed.
10. Life expectancy of at least 6 months as assessed by investigator.
11. Willing to initiate ARAT therapy determined by investigator.
12. For patients who have partners of childbearing potential: The patient and/or partner must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 6 months after the last study drug administration.
Exclusion Criteria
2. Prior treatment with radium-223 (Xofigo) within the past 12 weeks.
3. Prior chemotherapy treatment for castration-resistant prostate cancer. Prior docetaxel use in the hormone-sensitive setting is permitted, as long as no more than 6 doses were received, the last dose was administered \>1 year prior to consent, and disease progression did not occur during docetaxel treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
5. Patients with known HRR gene-mutation (BRCA 1/2 encompassing both germline and somatic) who have not been previously treated with olaparib or rucaparib.
6. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
7. Inadequate organ and bone marrow function as evidenced by:
1. Hemoglobin \< 8 g/dL.
2. Absolute neutrophil count \< 1.5 x 109/L.
3. Platelet count \< 100 x 109/L.
4. AST/SGOT and/or ALT/SGPT \> 3.0 x ULN.
5. Total bilirubin \> 2 x ULN unless patient has known Gilbert's syndrome and then may be 3 x ULN.
6. Creatinine clearance (CrCl) \< 50 mL/min based on the Cockcroft-Gault equation.
7. Albumin ≤ 2.75 g/dL
8. Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded.
9. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
10. Use of an investigational therapeutic drug within the last 4 weeks prior to start of study treatment or scheduled to receive one during the study period.
11. Known CNS metastasis unless received therapy, asymptomatic and neurologically stable.
12. Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization.
13. Major surgery within 30 days of randomization as determined by the Investigator.
14. Patients with active significant cardiac disease defined by any of the following:
1. New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the ICF unless treated with improvement.
2. Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias
3. History of long QT syndrome or know history of Torsades de Pointe
4. History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature
15. Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression
16. Patients with a superscan seen on baseline bone scan as determined by investigator.
17. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer
18. Previous use of G-CSF for persistent neutropenia after standard of care treatment.
19. Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy.
20. Participants with active Covid19. Recovered patients may be included when completely recovered (no symptoms at least 28 days before study medication and a negative Covid test within 72 hours).
18 Years
MALE
No
Sponsors
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Curium US LLC
INDUSTRY
Responsible Party
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Locations
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Arizona Institute of Urology, PPLC
Tucson, Arizona, United States
Providence Medical Foundation
Fullerton, California, United States
Long Beach Memorial Center
Long Beach, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
San Francisco VA Health Care System
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Providence Saint John's Health Center
Santa Monica, California, United States
GenesisCare USA
Boca Raton, Florida, United States
Biogenix Molecular LLC
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
GenesisCare USA
Plantation, Florida, United States
Florida Urology Partners, LLP
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Kaiser Permanente Gaithersburg Medical Center
Gaithersburg, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
BAMF Health I PC
Grand Rapids, Michigan, United States
Michigan Institute of Urology
Troy, Michigan, United States
GenesisCare USA
Troy, Michigan, United States
M Health Fairview Ridges Cancer Clinic
Burnsville, Minnesota, United States
SSM Saint Louis University Hospital
St Louis, Missouri, United States
Center for Clinical Theranostics Research, Washington University
St Louis, Missouri, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
OHSU - Center for health and healing
Portland, Oregon, United States
VA Portland Health Care System
Portland, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
CHU Brest
Brest, , France
Jean Perrin Comprehensive Cancer Center
Clermont-Ferrand, , France
Institute Paoli-Calmettes
Marseille, , France
Hôpital de Brabois -CHU
Nancy, , France
Institut de Cancérologie de l'Ouest (ICO) St Herblain
Nantes, , France
CHU Nimes
Nîmes, , France
ICANS
Strasbourg, , France
InstitutClaudius Regaud-IUCT-O
Toulouse, , France
University Clinic Bologna
Bologna, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Istituto Europeo di Oncologia (IEO) -IRCCS
Milan, , Italy
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
University Hospital of Salamanca
Salamanca, , Spain
Countries
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Other Identifiers
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CURLu177PSM0001
Identifier Type: -
Identifier Source: org_study_id
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