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Cu-SAR-bisPSMA for Prostate Cancer (SECuRE Trial)
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.
SECuRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSECuRE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SECuRE Trial Design
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Who is running the clinical trial?
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- My testosterone levels are very low.I haven't had certain radioactive treatments in the last 3-6 months.My PET/CT scan shows a lesion with higher activity than my liver.I can take care of myself and am up and about more than half of my waking hours.My cancer has grown by 20% or more, or I have new cancer spots since my last treatment.My prostate cancer is worsening despite hormone therapy and treatments like enzalutamide or abiraterone.My bone marrow functions well.I have a severe blockage in my urinary tract that can't be easily treated.I have not received a transfusion just to qualify for this study.My prostate cancer diagnosis was confirmed through lab tests.I am scheduled for external beam radiation therapy after joining the study.My PSA levels have increased twice in a row, with the last reading being over 2.0 ng/mL.My cancer has spread to my bones or gotten worse.I am 18 years old or older.I have cancer that has spread to my brain.My organs are functioning well.My kidneys are functioning well.My liver enzymes are within the required limits.I have had leukemia or Myelodysplastic Syndrome in the past.I have recovered from major side effects of my previous cancer treatments.I have been cancer-free for over 3 years, except for non-melanoma skin cancer or superficial bladder cancer.My prostate cancer is of the small cell or neuroendocrine type.I have not had major surgery in the last 12 weeks.My scans show my cancer is growing and does not show up on a specific PET/CT scan.I was diagnosed with a blood clot in my leg or lung in the last 4 weeks.I haven't had cancer treatment except for hormone therapy in the last 4 weeks.I have at least one cancer spread that shows on recent scans.I do not have serious health issues like severe heart failure or uncontrolled infections that would prevent me from participating in the study.You are expected to live for at least 6 more months.I have cancer spread to my spine causing or threatening to cause spinal cord pressure.
- Group 1: 67Cu-SAR-bisPSMA
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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