Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Trial ID or NCT#
NCT06056830
Status
RECRUITING
Purpose
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: 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.
Investigator(s)
Hong Song, MD, PhD
Assistant Professor of Radiology (Nuclear Medicine)
Contact us to find out if this trial is right for you.
Contact
David Marcellus
650-723-4547
View on ClinicalTrials.gov
