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

Phase 3RecruitingNCT06056830

Clarity Pharmaceuticals Ltd383 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

383

Conditions

Prostate Cancer Prostatic Neoplasms

Interventions

64Cu-SAR-bisPSMADRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

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.

Time frame: Up to 16 weeks

Secondary Outcomes

Safety and tolerability of 64Cu-SAR-bisPSMA

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

Time frame: Up to 16 weeks

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

Time frame: Up to 16 weeks

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

Time frame: Up to 16 weeks

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

Time frame: Up to 16 weeks

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

Time frame: Up to 16 weeks

Central Contacts

Clarity Pharmaceuticals

CONTACT

+61 (0) 2 9209 4037 clinicaltrials@claritypharmaceuticals.com

Data from ClinicalTrials.gov

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