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Radioisotope Therapy

177Lu-PSMA-I&T for Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by Curium US LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressive disease by one or more of the following criteria: Serum/plasma PSA progression, Progression of measurable disease or presence of at least two new bone lesions
Effective castration with serum testosterone level of <50 ng/dL
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 156 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new radioactive drug against standard hormone therapy in men with advanced prostate cancer that doesn't respond to usual treatments. The drug targets and kills cancer cells using radiation. The drug being tested, 225Ac-PSMA-617, has shown promise in inducing complete responses in patients with metastatic castrate-resistant prostate cancer who were resistant to standard therapies.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They must have tried and progressed on treatments like abiraterone or enzalutamide, but not more than one type. A positive PSMA-PET scan is needed, and they should be effectively castrated with low testosterone levels. HIV or hepatitis B/C patients may qualify if well-managed. Participants need a life expectancy of at least 6 months and agree to use contraception.
What is being tested?
This study compares the safety and effectiveness of a new treatment called 177Lu-PSMA-I&T against standard hormone therapies (abiraterone with prednisone or enzalutamide) in men whose prostate cancer has spread despite castration. It's an open-label trial where everyone knows which treatment they're getting, and it randomly assigns participants to either group.
What are the potential side effects?
Possible side effects for the new treatment include nausea, fatigue, dry mouth, changes in blood counts leading to increased risk of infection or bleeding, kidney damage, and temporary pain flare-ups in areas where cancer has spread.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened, shown by rising PSA levels, growth of tumors, or new bone lesions.
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My testosterone levels are below 50 ng/dL due to treatment.
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I have received ARAT for my cancer and it has progressed despite the treatment.
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My prostate cancer is confirmed without a major small cell component.
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I am willing to start ARAT therapy.
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I have been treated with advanced hormone therapy for cancer.
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I have had only one previous hormone therapy for cancer.
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I am a man over 18 and can sign a consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My physical functioning is somewhat limited.
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I have an HRR gene mutation and haven't been treated with olaparib or rucaparib.
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My organ and bone marrow functions are not meeting certain health standards.
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I am not currently receiving any other cancer treatments.
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I have been on a stable dose of zoledronic acid for bone therapy for at least 4 weeks.
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I have cancer, but it's not low-grade bladder cancer or non-melanoma skin cancer.
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I have not had radium-223 treatment in the last 3 months.
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I haven't used any experimental drugs in the last 4 weeks.
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I have a serious heart condition.
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I have used G-CSF for ongoing low white blood cell count after standard treatment.
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I have previously received treatment with radioligand therapy.
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I have symptoms or signs of potential spinal cord compression.
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I have not had major surgery in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~156 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 156 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Progression Free Survival
Secondary study objectives
Overall Survival (OS)
PSA50 Response Rate
Progression Free Survival
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational DrugExperimental Treatment1 Intervention
177Lu-PSMA-I\&T
Group II: Standard Of Care Hormone TherapyActive Control1 Intervention
Abiraterone with Prednisone or Enzalutamide

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Radioligand therapy, such as 177Lu-PSMA-I&T, targets the Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells, delivering radioactive particles directly to the tumor, thereby minimizing damage to surrounding healthy tissue. Hormone therapy reduces androgen levels or blocks their effects, slowing the growth of cancer cells that rely on these hormones. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while immunotherapy stimulates the patient's immune system to recognize and attack cancer cells. These treatments are crucial as they offer targeted, systemic, or immune-based approaches to manage and potentially reduce prostate cancer progression, improving patient outcomes and quality of life.
Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review.[<sup>177</sup>Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study.

Find a Location

Who is running the clinical trial?

Curium US LLCLead Sponsor
5 Previous Clinical Trials
572 Total Patients Enrolled
2 Trials studying Prostate Cancer
523 Patients Enrolled for Prostate Cancer

Media Library

177Lu-PSMA-I&T (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05204927 — Phase 3
Prostate Cancer Research Study Groups: Standard Of Care Hormone Therapy, Investigational Drug
Prostate Cancer Clinical Trial 2023: 177Lu-PSMA-I&T Highlights & Side Effects. Trial Name: NCT05204927 — Phase 3
177Lu-PSMA-I&T (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204927 — Phase 3
Prostate Cancer Patient Testimony for trial: Trial Name: NCT05204927 — Phase 3
~117 spots leftby Nov 2025