Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer (NCT06235151) | Clinical Trial Compass
RecruitingPhase 3
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
United States439 participantsStarted 2024-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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 interventional 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 study requirements.
* 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 scan.
* 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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.