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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

SECuRE Trial 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.

SECuRE Trial 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.
Select...
My bone marrow functions well.
Select...
My prostate cancer diagnosis was confirmed through lab tests.
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My PSA levels have increased twice in a row, with the last reading being over 2.0 ng/mL.
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My cancer has spread to my bones or gotten worse.
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My organs are functioning well.
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My kidneys are functioning well.
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My liver enzymes are within the required limits.
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I have recovered from major side effects of my previous cancer treatments.
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I have at least one cancer spread that shows on recent scans.

SECuRE Trial 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

SECuRE 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

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this research project?

"The sponsor, Clarity Pharmaceuticals Ltd, needs to enrol 44 patients that meet the study's inclusion criteria in order to run the trial out of multiple locations including Tulane Cancer Center, Tulane Medical School in New Orleans, Louisiana and Weill Cornell Medicine at New york-Presbyterian in New York, New York."

Answered by AI

Is this study exclusive to Canadian hospitals?

"This clinical trial is currently enrolling patients at Tulane Cancer Center, Tulane Medical School in New Orleans, Louisiana; Weill Cornell Medicine at New york-Presbyterian in New York, New York; GU Research Network in Omaha, Nebraska; and seven other locations."

Answered by AI

Are there any current openings for people who want to participate in this clinical trial?

"That is correct, based on the information available from clinicaltrials.gov, this study appears to be actively recruiting patients as of 11/2/2022. The trial was originally posted on 8/11/2021 and has since been edited. They are looking for 44 individuals total across 7 sites."

Answered by AI
~21 spots leftby Sep 2026