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

Clarity Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Prostatic Neoplasms; Prostate Cancer

Treatments: Drug: 64Cu-SAR-bisPSMA

Study type: Interventional

Funder types: Industry

Identifiers

NCT06056830

CLP04

Details and patient eligibility

About

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

Enrollment: 383 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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383 participants in 1 patient group

64Cu-SAR-bisPSMA

Experimental group

Description:

200MBq 64Cu-SAR-bisPSMA.

Treatment:

Drug: 64Cu-SAR-bisPSMA