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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hour

Awards & highlights

SABRE Trial 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.Check my eligibility

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.See study design

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.

SABRE Trial 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.

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My prostate cancer was confirmed by a biopsy and I've finished the main treatment.

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My PSA levels have risen by 2 ng/mL or more after prostate cancer treatment.

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My kidneys are functioning well.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

SABRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

SABRE 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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clarity Pharmaceuticals LtdLead Sponsor

10 Previous Clinical Trials

688 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for this scientific trial?

"This trial is actively recruiting, as demonstrated on clinicaltrials.gov; the study was first launched on September 19th 2022 and has undergone recent updates on September 28th of that same year."

Answered by AI

What is the size of the cohort involved in this research investigation?

"Clarity Pharmaceuticals Ltd requires 50 qualified individuals to conduct the clinical trial from two sites: Bamf Health, Inc in Grand Rapids and Advanced Molecular Imaging and Therapy in Glen Burnie."

Answered by AI

What risk factors have been observed with 64Cu-SAR-BBN exposure?

"64Cu-SAR-BBN exhibits a level 2 safety rating due to its Phase 2 trial status which has validated some of the drug's security, but there is no evidence yet for efficacy."

Answered by AI

In what quantity of medical facilities is this trial being administered?

"This medical trial is accepting patients from Bamf Health, Inc in Grand Rapids (Michigan), Advanced Molecular Imaging and Therapy in Glen Burnie (Maryland) as well as GU Research Network located in Omaha (Nebraska). Additionally, there are 4 other sites recruiting participants for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05407311.

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