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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well a PET scan using 64Cu-SAR-bisPSMA finds prostate cancer that has spread to nearby lymph nodes. It is for adults with untreated, high-risk prostate cancer who plan to have surgery to remove the prostate and nearby lymph nodes.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You sign a form agreeing to take part in the study.
  • A tissue test shows prostate adenocarcinoma, a type of prostate cancer, and it has not been treated.
  • Your cancer is high-risk or higher: its stage is T3a or higher, its Grade Group is 4 or higher, or your PSA blood test level is above 20 ng/mL.
  • You choose surgery to remove your prostate and nearby lymph nodes, which are small parts of the body's immune system.

Who can't join

  • You received a radioactive substance that gives off high-energy gamma rays (over 300 keV) too close to the first study day. The waiting time must be at least 5 half-lives—the time it takes for its radioactivity to drop by half, repeated 5 times.
  • You have a known or expected allergy to 64Cu-SAR-bisPSMA or any of its ingredients.
  • Your prostate cancer is known to be mostly small cell or neuroendocrine cancer, two specific types of prostate cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (29)

AL

AR

AZ

CA

FL

IL

  • NorthShore University Health System, Glenbrook Hospital · Glenview, IL 60026Brian Helfand, MD · Study contactMore trials in Glenview

IN

KS

MI

MN

NC

NE

NY

OK

OR

SC

TN

TX

UT

WI