TheranosticTrials.org
Clarity Pharmaceuticals

Clinical Trial · NCT05249127

64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

Overview

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 detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.

Sponsor

Clarity Pharmaceuticals

Phase

Phase 1/2

Contacts

Othon Gervasio (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT05249127

Eligibility

Inclusion

  • Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.
  • 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
  • For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.
  • 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).
  • 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:
  • Adequate liver function.
  • Estimated Glomerular Filtration Rate of 30 mL/min or higher.
  • Adequate recovery from acute toxic effects of any prior therapy.
  • Life expectancy ≥ 12 weeks as determined by the Investigator.
  • The Eastern Cooperative Oncology performance status 0-2.

Exclusion

  • Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  • 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.
  • Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
  • 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.

Patient Education

Patient education not yet provided.

Publications

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