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

NCT05204927 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CURLu177PSM0001
• Study Type: interventional
• Target: 439
• Locations: 4 countries
• Sites: 52

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.

Conditions

Metastasis From Malignant Tumor of Prostate

Keywords

Radioligand Therapy; Prostate Cancer; 177Lu-PSMA; PSMA; ECLIPSE

Outcome Measures

Primary Outcomes (1)

• Radiographic Progression Free Survival

  Radiographic progression free survival (rPFS), defined as the time from randomization to radiographic progression (using PCWG3 and RECIST 1.1 criteria as assessed by blinded independent central review \[BICR\]) or death due to any cause.

  34 weeks

Secondary Outcomes (9)

• Overall Survival (OS)

  156 weeks

• Second Radiographic Progression Free Survival (rPFS 2)

  156 weeks

• Progression Free Survival

  156 weeks

• Second Progression-Free Survival

  156 weeks

• PSA50 Response Rate

  156 weeks

Study Arms (2)

Standard Of Care Hormone Therapy

ACTIVE COMPARATOR

Abiraterone with Prednisone or Enzalutamide

Drug: Abiraterone with Prednisone or Enzalutamide

Investigational Drug

EXPERIMENTAL

177Lu-PSMA-I\&T

Drug: 177Lu-PSMA-I&T

Interventions

177Lu-PSMA-I&T DRUG

Radioligand therapy

Investigational Drug

Abiraterone with Prednisone or Enzalutamide DRUG

Hormone Therapy

Standard Of Care Hormone Therapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Curium US LLC: lead

Study Sites (52)

Arizona Institute of Urology, PPLC

Tucson, Arizona, 85704, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Long Beach Memorial Center

Long Beach, California, 90806, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

San Francisco VA Health Care System

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

GenesisCare USA

Boca Raton, Florida, 33431, United States

Location

Biogenix Molecular LLC

Miami, Florida, 33165, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

GenesisCare USA

Plantation, Florida, 33324, United States

Location

Florida Urology Partners, LLP

Tampa, Florida, 33607, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Kaiser Permanente Gaithersburg Medical Center

Gaithersburg, Maryland, 20879, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

BAMF Health I PC

Grand Rapids, Michigan, 49503, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

GenesisCare USA

Troy, Michigan, 48098, United States

Location

M Health Fairview Ridges Cancer Clinic

Burnsville, Minnesota, 55337, United States

Location

SSM Saint Louis University Hospital

St Louis, Missouri, 63104, United States

Location

Center for Clinical Theranostics Research, Washington University

St Louis, Missouri, 63110, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08993, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Central Ohio Urology Group

Gahanna, Ohio, 43230, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

OHSU - Center for health and healing

Portland, Oregon, 97239, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

CHU Brest

Brest, France

Location

Jean Perrin Comprehensive Cancer Center

Clermont-Ferrand, France

Location

Institute Paoli-Calmettes

Marseille, France

Location

Hôpital de Brabois -CHU

Nancy, France

Location

Institut de Cancérologie de l'Ouest (ICO) St Herblain

Nantes, France

Location

CHU Nimes

Nîmes, France

Location

ICANS

Strasbourg, France

Location

InstitutClaudius Regaud-IUCT-O

Toulouse, France

Location

University Clinic Bologna

Bologna, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Location

Istituto Europeo di Oncologia (IEO) -IRCCS

Milan, Italy

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, Spain

Location

University Hospital of Salamanca

Salamanca, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; Prednisone; enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized on a 2:1 basis to receive Lu177-PSMA (Investigational Arm) or standard of care hormone therapy (Control Arm). The Control Arm will consist of treatment with either abiraterone with prednisone or enzalutamide depending on the clinical judgement of the investigator. Participants who are randomized to the control arm who demonstrate radiographic progression may be eligible to crossover to receive Lu177-PSMA.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 24, 2022
• Study Start: February 14, 2022
• Primary Completion: August 2, 2024
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (37); ES (4); FR (8); IT (3)