Recruiting NCT06056830
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 64Cu-SAR-bisPSMA.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Prostatic Neoplasms. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Interventions
- Drug 64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Primary outcome measures
- Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases [Time frame: Up to 16 weeks]
Secondary outcome measures (5)
- Safety and tolerability of 64Cu-SAR-bisPSMA [Time frame: Up to 16 weeks]
- Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers [Time frame: Up to 16 weeks]
- PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs [Time frame: Up to 16 weeks]
- Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer [Time frame: Up to 16 weeks]
- Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching [Time frame: Up to 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 27 centers
- University of Alabama Birmingham Hospital — Birmingham
- Mayo Clinic- Phoenix — Phoenix
- Arkansas Urology Research Center, LLC — Little Rock
- Urology Group of Southern California — Los Angeles
- Greater Los Angeles VA Medical Center — Los Angeles
- UC Irvine Health — Orange
- Stanford University Medical Center — Stanford
- Mayo Clinic- Jacksonville — Jacksonville
- … and 19 more centers
Australia · 3 centers
- St. Vincent's Sydney — Sydney
- Princess Alexandra Hospital — Woolloongabba
- Fiona Stanley Hospital — Murdoch
Puerto Rico · 1 center
- Pan American Center for Oncology Trials, LLC - Ciudadela — San Juan
Identifiers
NCT: NCT06056830 · CLP04