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

Description

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic- Phoenix, Phoenix, Arizona, United States, 85054

Los Angeles

Greater Los Angeles VA Medical Center, Los Angeles, California, United States, 90073

Stanford

Stanford University Medical Center, Stanford, California, United States, 94305-5105

Jacksonville

Mayo Clinic- Jacksonville, Jacksonville, Florida, United States, 32224

Glenview

NorthShore University Health System, Glenview, Illinois, United States, 60026

Grand Rapids

BAMF Health, Grand Rapids, Michigan, United States, 49503

Grand Rapids

Corewell Health, Grand Rapids, Michigan, United States, 49503

Rochester

Mayo Clinic- Rochester, Rochester, Minnesota, United States, 55905

Omaha

XCancer Omaha LLC, Omaha, Nebraska, United States, 68130

Tulsa

Urologic Specialists, Tulsa, Oklahoma, United States, 74146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Clarity Pharmaceuticals Ltd,

Clarity Pharmaceuticals, STUDY_DIRECTOR, Clarity Pharmaceuticals

Study Record Dates

2025-02