RECRUITING

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

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Conditions

Prostate CancerProstatic Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-11-30
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06056830

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age.
  2. * Signed informed consent.
  3. * Untreated, histologically confirmed adenocarcinoma of the prostate.
  4. * 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).
  5. * Patients electing to undergo RP with PLND.
  1. * Administration of any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
  2. * Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  3. * Patients with known predominant small cell or neuroendocrine PC.

Contacts and Locations

Study Contact

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

Principal Investigator

Clarity Pharmaceuticals
STUDY_DIRECTOR
Clarity Pharmaceuticals

Study Locations (Sites)

Mayo Clinic- Phoenix
Phoenix, Arizona, 85054
United States
Greater Los Angeles VA Medical Center
Los Angeles, California, 90073
United States
Stanford University Medical Center
Stanford, California, 94305-5105
United States
Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224
United States
NorthShore University Health System
Glenview, Illinois, 60026
United States
BAMF Health
Grand Rapids, Michigan, 49503
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
Mayo Clinic- Rochester
Rochester, Minnesota, 55905
United States
XCancer Omaha LLC
Omaha, Nebraska, 68130
United States
Urologic Specialists
Tulsa, Oklahoma, 74146
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Urology Associates of Nashville
Nashville, Tennessee, 37209
United States
Urology Clinics of North Texas
Dallas, Texas, 75231
United States
UT Southwest Medical Center
Dallas, Texas, 75390-8896
United States
The Urology Place
San Antonio, Texas, 78240
United States
Intermountain Health
Murray, Utah, 84107
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Clarity Pharmaceuticals Ltd

  • Clarity Pharmaceuticals, STUDY_DIRECTOR, Clarity Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-30
Study Completion Date2025-02

Study Record Updates

Study Start Date2023-11-30
Study Completion Date2025-02

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Prostatic Neoplasms