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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

CLARIFY Trial 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.Check my eligibility

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.See study design

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.

CLARIFY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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My prostate cancer has not been treated and is confirmed by a biopsy.

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My prostate cancer is considered high-risk based on its stage, grade, or PSA levels.

CLARIFY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks

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

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

Primary outcome measures

Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases

Secondary outcome measures

Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer

Ability of 64Cu-SAR-bisPSMA PET to detect primary Prostate Cancer

Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers

+3 more

CLARIFY 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clarity Pharmaceuticals LtdLead Sponsor

10 Previous Clinical Trials

355 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

Frequently Asked Questions

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

Are individuals currently being recruited for participation in this research?

"According to clinicaltrials.gov, this research project is open for enrollment. This experiment initially went live on November 30th 2023 and has seen a recent update as of the same date."

Answered by AI

How many participants are currently signed up for this clinical research effort?

"Affirmative. The details published on clinicaltrials.gov disclose that recruitment for this medical research is currently underway, with the original posting date being November 30th 2023 and most recent edits occurring in the same month. 383 individuals are required to be enrolled from 1 centre."

Answered by AI