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Metastasis From Malignant Tumor of ProstatePhase 3NCT05204927

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

A Phase 3 study testing 177Lu-PSMA-I&T and Abiraterone with Prednisone or Enzalutamide in people with Metastasis From Malignant Tumor of Prostate, run by Curium US LLC at 52 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
177Lu-PSMA-I&T and Abiraterone with Prednisone or Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
439 participants
Where
52 sitesin 4 countries
Study dates
14 Feb 2022to Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

52 sites in 4 countries.

52 sites in 4 countries

United States37 sites

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • John Hopkins Hospital

    Baltimore, Maryland, 21287

  • GenesisCare USA

    Boca Raton, Florida, 33431

  • M Health Fairview Ridges Cancer Clinic

    Burnsville, Minnesota, 55337

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

  • Kaiser Permanente Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • BAMF Health I PC

    Grand Rapids, Michigan, 49503

  • Houston Metro Urology

    Houston, Texas, 77027

  • Long Beach Memorial Center

    Long Beach, California, 90806

  • Biogenix Molecular LLC

    Miami, Florida, 33165

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08993

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • XCancer Omaha / Urology Cancer Center

    Omaha, Nebraska, 68130

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • GenesisCare USA

    Plantation, Florida, 33324

  • OHSU - Center for health and healing

    Portland, Oregon, 97239

  • VA Portland Health Care System

    Portland, Oregon, 97239

  • Urology San Antonio

    San Antonio, Texas, 78229

  • San Francisco VA Health Care System

    San Francisco, California, 94121

  • University of California, San Francisco

    San Francisco, California, 94158

  • Providence Saint John's Health Center

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • SSM Saint Louis University Hospital

    St Louis, Missouri, 63104

  • Center for Clinical Theranostics Research, Washington University

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Florida Urology Partners, LLP

    Tampa, Florida, 33607

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • GenesisCare USA

    Troy, Michigan, 48098

  • Arizona Institute of Urology, PPLC

    Tucson, Arizona, 85704

Other trials in United States

France8 sites

  • CHU Brest

    Brest

  • Jean Perrin Comprehensive Cancer Center

    Clermont-Ferrand

  • Institute Paoli-Calmettes

    Marseille

  • Hôpital de Brabois -CHU

    Nancy

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

    Nantes

  • CHU Nimes

    Nîmes

  • ICANS

    Strasbourg

  • InstitutClaudius Regaud-IUCT-O

    Toulouse

Other trials in France

Spain4 sites

  • Fundación Jiménez Díaz

    Madrid

  • Hospital Universitario HM Sanchinarro

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga

  • University Hospital of Salamanca

    Salamanca

Other trials in Spain

Italy3 sites

  • University Clinic Bologna

    Bologna

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

  • Istituto Europeo di Oncologia (IEO) -IRCCS

    Milan

Other trials in Italy

About this study

Official title: 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

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.

Read the 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 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 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.

Being tested
177Lu-PSMA-I&T, Abiraterone with Prednisone or Enzalutamide
Keywords
Radioligand Therapy, Prostate Cancer, 177Lu-PSMA, PSMA, ECLIPSE
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA-I&TDrug

    Radioligand therapy

  • Abiraterone with Prednisone or EnzalutamideDrug

    Hormone Therapy

Study groups in NCT05204927
Study groupRoleWhat they receive
Standard Of Care Hormone TherapyActive comparatorAbiraterone with Prednisone or Enzalutamide
Receives: Drug: Abiraterone with Prednisone or Enzalutamide
Investigational DrugExperimental177Lu-PSMA-I\&T
Receives: Drug: 177Lu-PSMA-I&T

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 34 weeks

Secondary outcomes (9)

  1. Overall Survival (OS)

    Time (weeks) from randomization to death due to any cause.

    Measured: 156 weeks

  2. Second Radiographic Progression Free Survival (rPFS 2)

    Time from randomization to the second radiographic progression or death in participants who crossover.

    Measured: 156 weeks

  3. Progression Free Survival

    First occurrence of PCWG3 progression, clinical/symptomatic progression and/or pain progression, or death due to any cause.

    Measured: 156 weeks

  4. Second Progression-Free Survival

    Second occurrence of PCWG3 progression, clinical/symptomatic progression and/or pain progression, or death due to any cause.

    Measured: 156 weeks

  5. PSA50 Response Rate

    Response rate of patients who achieve a reduction of ≥50% in PSA from the baseline PSA assessment.

    Measured: 156 weeks

  6. Time to First Symptomatic Skeletal Event (SSE)

    Occurrence of either bone-directed radiotherapy to relieve bone pain, new symptomatic pathologic fractures, spinal cord compression, or tumor-related orthopedic surgery.

    Measured: 156 weeks

  7. Time to Soft Tissue Progression (STP)

    Occurrence of radiographic progression in soft tissue.

    Measured: 156 weeks

  8. Time to Chemotherapy (TTC)

    Time from randomization to the initiation of chemotherapy or death.

    Measured: 156 weeks

  9. Quality of Life Questionnaire- EORTC QLQ-C30

    The Quality of Life (QoL) will be assessed via European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a questionnaire of thirty quality of life (QoL) questions developed to assess the QoL of cancer patients. The EORTC QLQ-C30 comprises 30 items, 24 of which are aggregated into nine multi-item scales, which are scored from 0 to 100.

    Measured: 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start14 Feb 2022
  3. Primary completion2 Aug 2024
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204927
Sponsor's protocol ID
CURLu177PSM0001
Status last verified
Aug 2026
First submitted
1 Dec 2021
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 177Lu-PSMA-I&T and Abiraterone with Prednisone or Enzalutamide in people with Metastasis From Malignant Tumor of Prostate, run by Curium US LLC at 52 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, France, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression Free Survival (time frame: 34 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05204927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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