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

Purpose

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

Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama Birmingham Hospital
Birmingham, Alabama 35249-6830
Contact:
Ashley Barnes
205-996-5784
alstrickland@uabmc.edu

More Details

Status
Recruiting
Sponsor
Clarity Pharmaceuticals Ltd

Study Contact

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