Status:
COMPLETED
64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)
Lead Sponsor:
Clarity Pharmaceuticals Ltd
Conditions:
Biochemical Recurrence of Malignant Neoplasm of Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly...
Detailed Description
Participants with biochemical evidence of recurrence of PC were evaluated with 64CU-SAR-bisPSMA PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later, eg. Histopathology/biop...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Signed informed consent.
- Life expectancy ≥ 12 weeks as determined by the Investigator.
- Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
- Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of:
- Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
- Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).
- Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.
- The Eastern Cooperative Oncology performance status 0-2.
- Adequate recovery from acute toxic effects of any prior therapy.
- Estimated Glomerular Filtration Rate of 30 mL/min or higher.
- Adequate liver function.
- For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.
Exclusion
- Participants who received other investigational agents within 28 days prior to Day 0.
- Participants administered any high energy (\>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
- Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
- Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05249127
Start Date
April 11 2022
End Date
August 8 2023
Last Update
October 1 2024
Active Locations (5)
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1
Tower Urology
Los Angeles, California, United States, 90048
2
GU Research Network
Omaha, Nebraska, United States, 68130
3
New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87109
4
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572