Recruiting at 34 sites Phase 3 Prostate Cancer

Prostate Cancer study: 64Cu-SAR-bisPSMA

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

ClinicalTrials.gov ID: NCT06056830

What this study is testing

What is 64Cu-SAR-bisPSMA?

This is an investigational radioactive imaging agent being studied to help detect prostate cancer spread in the lymph nodes. It is designed to attach to specific proteins on prostate cancer cells so that a scanner can see where the cancer is located.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to see how well the 64Cu‑SAR‑bisPSMA PET scan detects cancer spread to nearby lymph nodes.
Who it's for
Men with high‑risk prostate cancer who are scheduled for radical prostatectomy.
What's involved
Participants will have a PET scan using the 64Cu‑SAR‑bisPSMA tracer to image their lymph nodes.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, men only

You may be able to join if

  • 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...
  • Patients electing to undergo RP with PLND.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it is enrolling

  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Stanford, California, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Glenview, Illinois, United States
  • Indianapolis, Indiana, United States
  • Wichita, Kansas, United States
  • Grand Rapids, Michigan, United States
  • Rochester, Minnesota, United States
  • Omaha, Nebraska, United States
  • Albany, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Tulsa, Oklahoma, United States
  • Springfield, Oregon, United States
  • Myrtle Beach, South Carolina, United States

+ 11 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; Stanford, California, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.