Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

Prostate Cancer Clinical Trial

— CLARIFY  

Official title:

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056830
• Other study ID #: CLP04
• Status: Recruiting
• Phase: Phase 3
• Start date: November 30, 2023
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Clarity Pharmaceuticals Ltd
• Contact: Clarity Pharmaceuticals
• Phone: +61 (0) 2 9209 4037
• Email: clinicaltrials[@]claritypharmaceuticals.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 383
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age.
• Signed informed consent.
• Untreated, histologically confirmed adenocarcinoma of the prostate.
• High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage =T3a, or Grade Group =4, or PSA >20 ng/mL).
• Patients electing to undergo RP with PLND.

Exclusion Criteria:

• Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
• Patients with known predominant small cell or neuroendocrine PC.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Locations

Country	Name	City	State
United States	Urology Clinics of North Texas	Dallas	Texas
United States	NorthShore University Health System	Glenview	Illinois
United States	Intermountain Health	Murray	Utah
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	XCancer Omaha LLC	Omaha	Nebraska
United States	The Urology Place	San Antonio	Texas
United States	Urologic Specialists	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Clarity Pharmaceuticals Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases	Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.	Up to 16 weeks
Secondary	Safety and tolerability of 64Cu-SAR-bisPSMA	Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA	Up to 16 weeks
Secondary	Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers	Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic	Up to 16 weeks
Secondary	PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs	PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth	Up to 16 weeks
Secondary	Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer	Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth	Up to 16 weeks
Secondary	Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching	Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth	Up to 16 weeks