Can a radioactive 'Smart Bomb' outsmart advanced prostate cancer?

NCT ID NCT05204927

Disease control Sponsor: Curium US LLC Source: ClinicalTrials.gov ↗

First seen Aug 13, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether a new type of targeted radiation therapy, called 177Lu-PSMA-I&T, can slow the progression of metastatic castration-resistant prostate cancer better than standard hormone therapy. The study enrolls men with prostate cancer that has spread and no longer responds to hormone treatment. Participants are randomly assigned to receive either the radioligand therapy or a hormone therapy (abiraterone with prednisone, or enzalutamide). The main goal is to see how long the cancer stays under control before it progresses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: 177Lu-PSMA-I&T, a radioligand therapy that delivers targeted radiation to prostate cancer cells
What this could lead to: If successful, this could offer a new, more effective treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong: This is a phase 3 trial, but results are not guaranteed. The treatment may not prove superior to hormone therapy, and radiation therapy carries risks like damage to healthy tissues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

439 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male 18 years or older able to understand and provide signed written informed consent. 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: 1. Prior treatment with radioligand therapy including other lutetium-labeled compounds. 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).

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastasis from malignant tumor of prostate

Contacts and locations

Locations

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy
Arizona Institute of Urology, PPLC

Tucson, Arizona, 85704, United States
BAMF Health I PC

Grand Rapids, Michigan, 49503, United States
Biogenix Molecular LLC

Miami, Florida, 33165, United States
CHU Brest

Brest, France
CHU Nimes

Nîmes, France
Center for Clinical Theranostics Research, Washington University

St Louis, Missouri, 63110, United States
Central Ohio Urology Group

Gahanna, Ohio, 43230, United States
Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032, United States
Florida Urology Partners, LLP

Tampa, Florida, 33607, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
Fundación Jiménez Díaz

Madrid, Spain
GenesisCare USA

Boca Raton, Florida, 33431, United States
GenesisCare USA

Plantation, Florida, 33324, United States
GenesisCare USA

Troy, Michigan, 48098, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States
Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States
Hospital Regional Universitario de Malaga

Málaga, Spain
Hospital Universitario HM Sanchinarro

Madrid, Spain
Houston Metro Urology

Houston, Texas, 77027, United States
Hôpital de Brabois -CHU

Nancy, France
ICANS

Strasbourg, France
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Institut de Cancérologie de l'Ouest (ICO) St Herblain

Nantes, France
InstitutClaudius Regaud-IUCT-O

Toulouse, France
Institute Paoli-Calmettes

Marseille, France
Istituto Europeo di Oncologia (IEO) -IRCCS

Milan, Italy
Jean Perrin Comprehensive Cancer Center

Clermont-Ferrand, France
John Hopkins Hospital

Baltimore, Maryland, 21287, United States
Kaiser Permanente Gaithersburg Medical Center

Gaithersburg, Maryland, 20879, United States
Long Beach Memorial Center

Long Beach, California, 90806, United States
M Health Fairview Ridges Cancer Clinic

Burnsville, Minnesota, 55337, United States
Michigan Institute of Urology

Troy, Michigan, 48084, United States
MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States
NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
OHSU - Center for health and healing

Portland, Oregon, 97239, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States
Orlando Health Cancer Institute

Orlando, Florida, 32806, United States
Providence Medical Foundation

Fullerton, California, 92835, United States
Providence Saint John's Health Center

Santa Monica, California, 90404, United States
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08993, United States
SSM Saint Louis University Hospital

St Louis, Missouri, 63104, United States
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
San Francisco VA Health Care System

San Francisco, California, 94121, United States
University Clinic Bologna

Bologna, Italy
University Hospital of Salamanca

Salamanca, Spain
University of California, San Francisco

San Francisco, California, 94158, United States
Urology San Antonio

San Antonio, Texas, 78229, United States
VA Portland Health Care System

Portland, Oregon, 97239, United States
XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, 68130, United States

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