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Radioisotope Therapy

Cu-SAR-bisPSMA for Prostate Cancer (SECuRE Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Clarity Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value [SUV] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan
Must not have
Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study.
Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new cancer treatment for men with metastatic prostate cancer that has continued to grow despite hormone therapy. They will be testing to see if this new treatment is safe and effective.

Who is the study for?
Men over 18 with metastatic castrate resistant prostate cancer that's gotten worse despite treatment, and who have a certain level of organ function. They must not have brain metastases, small cell or neuroendocrine prostate cancer, recent major surgery, or other serious health issues. Participants need to use birth control if applicable.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of two radioactive drugs called 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA in targeting and treating advanced prostate cancer that shows up on special PET/CT scans.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, nausea, fatigue, blood count changes which could lead to increased infection risk or bleeding problems. There might also be kidney function changes due to the drug's radioactivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My testosterone levels are very low.
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My PET/CT scan shows a lesion with higher activity than my liver.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer has grown by 20% or more, or I have new cancer spots since my last treatment.
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My prostate cancer is worsening despite hormone therapy and treatments like enzalutamide or abiraterone.
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My prostate cancer diagnosis was confirmed through lab tests.
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My cancer has spread to my bones or gotten worse.
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My kidneys are functioning well.
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My liver enzymes are within the required limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for external beam radiation therapy after joining the study.
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I haven't had certain radioactive treatments in the last 3-6 months.
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I have a severe blockage in my urinary tract that can't be easily treated.
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I have not received a transfusion just to qualify for this study.
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I have cancer that has spread to my brain.
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I have had leukemia or Myelodysplastic Syndrome in the past.
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My prostate cancer is of the small cell or neuroendocrine type.
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My scans show my cancer is growing and does not show up on a specific PET/CT scan.
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I was diagnosed with a blood clot in my leg or lung in the last 4 weeks.
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I have cancer spread to my spine causing or threatening to cause spinal cord pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biodistribution of 64Cu-SAR-bisPSMA
Dosimetry of 64Cu-SAR-bisPSMA
Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 67Cu-SAR-bisPSMAExperimental Treatment2 Interventions
In the dosimetry phase patients will receive a single 200 MBq administration of 64Cu-SAR-bisPSMA. In the dose escalation phase patients will receive up to 2 administrations of 200 MBq of 64Cu-SAR-bisPSMA. In the cohort expansion phase patients will receive up to 3 administrations of 200 MBq of 64Cu-SAR-bisPSMA. In the dose escalation phase patients will receive up to 2 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation). In the cohort expansion phase patients will receive 2 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
64Cu-SAR-bisPSMA
2022
Completed Phase 2
~90

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
Prostate cancer treatments, particularly targeted radiotherapies like 67Cu-SAR-bisPSMA, work by binding to Prostate-Specific Membrane Antigen (PSMA) expressed on cancer cells. This allows for the delivery of radioactive isotopes directly to the tumor, minimizing damage to surrounding healthy tissue. Other common treatments include androgen receptor inhibitors (e.g., enzalutamide) that block the effects of androgens, and chemotherapy agents (e.g., docetaxel) that kill rapidly dividing cells. These mechanisms are crucial as they offer targeted, effective options for managing prostate cancer, especially in advanced stages where traditional therapies may be less effective.
Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review.

Find a Location

Who is running the clinical trial?

Clarity Pharmaceuticals LtdLead Sponsor
10 Previous Clinical Trials
697 Total Patients Enrolled
2 Trials studying Prostate Cancer
413 Patients Enrolled for Prostate Cancer
Clarity PharmaceuticalsStudy DirectorClarity Pharmaceuticals
2 Previous Clinical Trials
421 Total Patients Enrolled
1 Trials studying Prostate Cancer
383 Patients Enrolled for Prostate Cancer

Media Library

67Cu-SAR-bisPSMA (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04868604 — Phase 1 & 2
Prostate Cancer Research Study Groups: 67Cu-SAR-bisPSMA
Prostate Cancer Clinical Trial 2023: 67Cu-SAR-bisPSMA Highlights & Side Effects. Trial Name: NCT04868604 — Phase 1 & 2
67Cu-SAR-bisPSMA (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04868604 — Phase 1 & 2
~18 spots leftby Sep 2026