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64Cu-SAR-bisPSMA PET Scan for Prostate Cancer (CLARIFY Trial)

Phase 3
Recruiting
Research Sponsored by Clarity Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age.
Untreated, histologically confirmed adenocarcinoma of the prostate.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial assesses if PET scans can detect cancer spread in the lymph nodes to help with diagnosis.

Who is the study for?
This trial is for men at least 18 years old with high-risk prostate cancer, as defined by specific clinical stages, grade groups, or PSA levels. Participants must be planning to undergo radical prostatectomy with lymph node dissection and have not received prior treatment for their confirmed adenocarcinoma of the prostate.
What is being tested?
The study is testing a diagnostic procedure using a PET scan with a tracer called 64Cu-SAR-bisPSMA. The goal is to see how well this method can identify if the cancer has spread to regional lymph nodes in patients scheduled for surgery.
What are the potential side effects?
Potential side effects are not specified here but generally, PET scans are considered safe. However, there may be risks related to allergic reactions to the tracer or discomfort from the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My prostate cancer has not been treated and is confirmed by a biopsy.
Select...
My prostate cancer is considered high-risk based on its stage, grade, or PSA levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
Secondary study objectives
Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching
+2 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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
200MBq 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
359 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer
Clarity PharmaceuticalsStudy DirectorClarity Pharmaceuticals
2 Previous Clinical Trials
82 Total Patients Enrolled
~55 spots leftby Feb 2025
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