Status:
ACTIVE_NOT_RECRUITING
177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Curium US LLC
Conditions:
Metastasis From Malignant Tumor of Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I\&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.
Detailed Description
This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I\&T as treatment compared to standard of care hormone therapy in men with metastatic Castrati...
Eligibility Criteria
Inclusion
- Male 18 years or older able to understand and provide signed written informed consent.
- Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
- Progressive disease by one or more of the following criteria:
- 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.
- Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria).
- Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide).
- Must have received no more than one previous AR-directed therapy.
- Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting.
- Must have progressed while on ARAT.
- PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader.
- Effective castration with serum testosterone level of \<50 ng/dL and plan to continue with chronic medical or surgical castration.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- 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.
- Patients with HBV and HCV may also participate if symptoms are sufficiently managed.
- Life expectancy of at least 6 months as assessed by investigator.
- Willing to initiate ARAT therapy determined by investigator.
- 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
- Prior treatment with radioligand therapy including other lutetium-labeled compounds.
- Prior treatment with radium-223 (Xofigo) within the past 12 weeks.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
- Patients with known HRR gene-mutation (BRCA 1/2 encompassing both germline and somatic) who have not been previously treated with olaparib or rucaparib.
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- Inadequate organ and bone marrow function as evidenced by:
- Hemoglobin \< 8 g/dL.
- Absolute neutrophil count \< 1.5 x 109/L.
- Platelet count \< 100 x 109/L.
- AST/SGOT and/or ALT/SGPT \> 3.0 x ULN.
- Total bilirubin \> 2 x ULN unless patient has known Gilbert's syndrome and then may be 3 x ULN.
- Creatinine clearance (CrCl) \< 50 mL/min based on the Cockcroft-Gault equation.
- Albumin ≤ 2.75 g/dL
- Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded.
- Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
- 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.
- Known CNS metastasis unless received therapy, asymptomatic and neurologically stable.
- Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization.
- Major surgery within 30 days of randomization as determined by the Investigator.
- Patients with active significant cardiac disease defined by any of the following:
- New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the ICF unless treated with improvement.
- Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias
- History of long QT syndrome or know history of Torsades de Pointe
- History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature
- Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression
- Patients with a superscan seen on baseline bone scan as determined by investigator.
- Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer
- Previous use of G-CSF for persistent neutropenia after standard of care treatment.
- 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.
- 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).
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2029
Estimated Enrollment :
439 Patients enrolled
Trial Details
Trial ID
NCT05204927
Start Date
February 14 2022
End Date
February 1 2029
Last Update
July 31 2025
Active Locations (52)
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1
Arizona Institute of Urology, PPLC
Tucson, Arizona, United States, 85704
2
Providence Medical Foundation
Fullerton, California, United States, 92835
3
Long Beach Memorial Center
Long Beach, California, United States, 90806
4
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663