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

• Sponsor: Clarity Pharmaceuticals Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06056830
• Collaborator: (none)
• Enrollment: 383
• Arm: 1
• Anticipated Duration (Months): 15

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostatic Neoplasms	Drug: 64Cu-SAR-bisPSMA	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 383 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.	Drug: 64Cu-SAR-bisPSMA; All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Outcome Measures

Primary Outcome Measures

1. Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases [Up to 16 weeks]

   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.

Secondary Outcome Measures

1. Safety and tolerability of 64Cu-SAR-bisPSMA [Up to 16 weeks]

   Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA

2. Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers [Up to 16 weeks]

   Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic

3. PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs [Up to 16 weeks]

   PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth

4. Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer [Up to 16 weeks]

   Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth

5. Ability of 64Cu-SAR-bisPSMA PET to detect primary Prostate Cancer [Up to 16 weeks]

   Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth

6. Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching [Up to 16 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Clarity Pharmaceuticals Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clarity Pharmaceuticals Ltd
• ClinicalTrials.gov Identifier: NCT06056830
• Other Study ID Numbers: CLP04
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Sep 28, 2023