64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA) (NCT05249127) | Clinical Trial Compass
CompletedPhase 1/2
64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)
United States52 participantsStarted 2022-04-11
Plain-language 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 detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.
Who can participate
Age range18 Years
SexMALE
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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 conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.
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.
What they're measuring
1
Safety and Tolerability
Timeframe: up to 7 days post injection
2
Participant-level Correct Detection Rate (CDR)- Day 0
Timeframe: Day 0 (1- 4 hours) post injection
3
Participant-level CDR- Day 1
Timeframe: Day 1 (24+/-6 Hours) post injection
4
Region-level Positive Predictive Value (PPV)- Day 0
✕. 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.