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New treatment option for Prostate Cancer
Official title Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
ClinicalTrials.gov ID: NCT06235151
What this study is testing
What is Copper Cu 64 PSMA I&T?
Copper Cu 64 PSMA I&T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
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
- This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
- Phase 3: a large, late-stage study
- This is a blinded 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
- Patients with histologically proven prostate adenocarcinoma.
- Planned prostatectomy with pelvic lymph node dissection.
- Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
- Male aged greater than or equal to 18 years.
- Able to understand and provide signed written informed consent.
You likely can't join if
- Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy...
- Patients participating in an treatment clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological...
- Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes...
- Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If...
- Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper...
- Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
See the full eligibility criteria
- Patients with histologically proven prostate adenocarcinoma.
- Planned prostatectomy with pelvic lymph node dissection.
- Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
- Male aged greater than or equal to 18 years.
- Able to understand and provide signed written informed consent.
- Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.
- Patients participating in an treatment clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.
- Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfill the...
- Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET...
- Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration.
- Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
- Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Little Rock, Arkansas, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Stanford, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Hines, Illinois, United States
- Carmel, Indiana, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Glen Burnie, Maryland, United States
- Boston, Massachusetts, United States
+ 19 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 - 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?
Study sites include Homewood, Alabama, United States; Little Rock, Arkansas, United States; Fullerton, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Orange, California, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.