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64Cu-SAR-BBN Imaging for Prostate Cancer (SABRE Trial)

Phase 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
- 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
Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
Must not have
Known or expected hypersensitivity to 64Cu-SAR-BBN or any of its components.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new cancer-detecting compound to see if it is safe and effective. It will also study if this compound can help find cancer that has come back after treatment.

Who is the study for?
This trial is for adults with suspected recurrent prostate cancer after initial treatment, who have a life expectancy of at least 12 weeks. They should have rising PSA levels and negative or unclear results from standard imaging and PSMA PET scans. Participants must be in relatively good health, with proper kidney and liver function, and willing to use birth control if necessary.
What is being tested?
The study tests the safety and effectiveness of a compound called 64Cu-SAR-BBN used in PET/CT scans to detect prostate cancer recurrence in patients whose tumors do not show up on PSMA-targeted scans. The goal is to see how well this new method identifies cancer that has returned.
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the injection of the tracer compound (64Cu-SAR-BBN), such as allergic reactions or discomfort at the injection site. As it's an investigational product, participants will be monitored closely for any unexpected side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My PSA levels are rising and confirmed to be 0.2 ng/mL or higher after prostate surgery.
Select...
My prostate cancer was confirmed by a biopsy and I've finished the main treatment.
Select...
My PSA levels have risen by 2 ng/mL or more after prostate cancer treatment.
Select...
My kidneys are functioning well.
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I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to 64Cu-SAR-BBN or its ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of 64Cu-SAR-BBN Treatment-Emergent Adverse Events and Serious Adverse Events [Safety and Tolerability]
Participant-level correct detection rate
Region-level positive predictive value

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-BBNExperimental Treatment1 Intervention
Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-BBN.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
64Cu-SAR-BBN
2022
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Clarity Pharmaceuticals LtdLead Sponsor
10 Previous Clinical Trials
689 Total Patients Enrolled
2 Trials studying Prostate Cancer
413 Patients Enrolled for Prostate Cancer

Media Library

64Cu-SAR-BBN Clinical Trial Eligibility Overview. Trial Name: NCT05407311 — Phase 2
Prostate Cancer Research Study Groups: 64Cu-SAR-BBN
Prostate Cancer Clinical Trial 2023: 64Cu-SAR-BBN Highlights & Side Effects. Trial Name: NCT05407311 — Phase 2
64Cu-SAR-BBN 2023 Treatment Timeline for Medical Study. Trial Name: NCT05407311 — Phase 2
~17 spots leftby Dec 2025
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