Prostate Cancer Clinical Trial

64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

Summary

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with PSMA-negative biochemical recurrence of prostate cancer following definitive therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 (1) approved PSMA PET and (2) anatomical imaging (CT and/or magnetic resonance imaging) and (3) if available, any other conventional imaging performed as part of routine standard of care imaging 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 Criteria:

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-BBN 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.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT05407311

Recruitment Status:

Recruiting

Sponsor:

Clarity Pharmaceuticals Ltd

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There are 4 Locations for this study

See Locations Near You

Stanford University
Stanford California, 94305, United States More Info
Hong Song, MD
Principal Investigator
Advanced Molecular Imaging and Therapy
Glen Burnie Maryland, 21061, United States More Info
Michael Morris, MD
Principal Investigator
Bamf Health, Inc
Grand Rapids Michigan, 49503, United States More Info
Brandon Mancini, MD
Principal Investigator
GU Research Network
Omaha Nebraska, 68130, United States More Info
Tony Romero
Contact
402-690-3716
[email protected]
Luke Nordquist, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT05407311

Recruitment Status:

Recruiting

Sponsor:


Clarity Pharmaceuticals Ltd

How clear is this clinincal trial information?

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