Prostate Cancer Clinical Trial

Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer

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.

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Full 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 Castration-Resistant Prostate Cancer.

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 4 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.

From the patients randomized into the 177Lu-PSMA-I&T arm, a total of 30 patients will be enrolled invited to participate in the a pharmacokinetic and radiation dosimetry sub-study at selected participating clinical sites. Sub-study participants will receive planar and SPECT imaging after each treatment cycle for dosimetry analysis.

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Eligibility Criteria

Inclusion Criteria:

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 ngdL 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 Criteria:

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-sensitive or castration-resistant prostate cancer (docetaxel or cabazitaxel).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
Patients with known HRR gene-mutation 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).

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT05204927

Recruitment Status:

Recruiting

Sponsor:

Curium US LLC

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There are 29 Locations for this study

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University of Alabama at Birmingham Hospital
Birmingham Alabama, 35249, United States
Arizona Institute of Urology, PPLC
Tucson Arizona, 85704, United States
Providence Medical Foundation
Fullerton California, 92835, United States
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States
San Francisco VA Health Care System
San Francisco California, 94121, United States
University of California, San Francisco
San Francisco California, 94158, United States
Providence Saint John's Health Center
Santa Monica California, 90404, United States
GenesisCare USA
Boca Raton Florida, 33431, United States
GenesisCare USA
Fort Myers Florida, 33908, United States
GenesisCare USA
Jacksonville Florida, 32256, United States
Biogenix Molecular LLC
Miami Florida, 33165, United States
GenesisCare USA
Plantation Florida, 33324, United States
Florida Urology Partners, LLP
Tampa Florida, 33607, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston Illinois, 60201, United States
John Hopkins Hospital
Baltimore Maryland, 21287, United States
Kaiser Permanente Gaithersburg Medical Center
Gaithersburg Maryland, 20879, United States
BAMF Health I PC
Grand Rapids Michigan, 49503, United States
GenesisCare USA
Troy Michigan, 48098, United States
M Health Fairview Ridges Cancer Clinic
Burnsville Minnesota, 55337, United States
SSM Saint Louis University Hospital
Saint Louis Missouri, 63104, United States
GU Research Network/ urology Cancer Center
Omaha Nebraska, 68130, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08993, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York New York, 10032, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
OHSU - Center for health and healing
Portland Oregon, 97239, United States
VA Portland Health Care System
Portland Oregon, 97239, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Houston Metro Urology
Houston Texas, 77027, United States
Excel Diagnostics & Nuclear Oncology Center
Houston Texas, 77042, United States
Urology San Antonio
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT05204927

Recruitment Status:

Recruiting

Sponsor:


Curium US LLC

How clear is this clinincal trial information?

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