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

Phase 1 & 2
Waitlist Available
Research Sponsored by Clarity Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (1- 4 hours)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new imaging agent called 64Cu-SAR-bisPSMA. It helps doctors see if prostate cancer has come back in patients who have already been treated. The agent works by attaching to cancer cells and making them visible on PET/CT scans.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (1- 4 hours) post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (1- 4 hours) post injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant-level CDR- Day 1
Participant-level Correct Detection Rate (CDR)- Day 0
Region-level PPV- Day 1
+2 more
Secondary study objectives
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
+7 more

Side effects data

From 2023 Phase 1 & 2 trial • 52 Patients • NCT05249127
2%
urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Analysis Set

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 64Cu-SAR-bisPSMAExperimental Treatment1 Intervention
Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
64Cu-SAR-bisPSMA
2022
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Clarity Pharmaceuticals LtdLead Sponsor
10 Previous Clinical Trials
690 Total Patients Enrolled
2 Trials studying Prostate Cancer
413 Patients Enrolled for Prostate Cancer
Othon GervasioStudy DirectorClarity Pharmaceuticals
~14 spots leftby Dec 2025
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