Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Launched by CURIUM US LLC · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a new imaging technique called copper Cu 64 PSMA I&T PET/CT scanning to help doctors see and evaluate prostate cancer in men who have recently been diagnosed. The study is focused on men with specific types of prostate cancer that are considered to be at an intermediate to very high risk according to established medical guidelines. By using this imaging method, researchers hope to improve the way doctors assess the cancer before surgery, which could lead to better treatment decisions.

To be eligible for this study, participants must be men aged 18 and older who have been confirmed to have prostate cancer and are scheduled to undergo surgery to remove the prostate and nearby lymph nodes. They should not have received any treatments like hormone therapy or chemotherapy before joining the trial. If you decide to participate, you will receive the copper Cu 64 PSMA I&T injection before your PET scan, and the study team will carefully monitor your experience. It’s important to note that certain conditions, like having had a recent PET scan or certain kinds of medical imaging, may prevent you from participating. This trial is currently recruiting participants, so it’s a great opportunity to contribute to important research in prostate cancer care.

Gender

MALE

Eligibility criteria

• 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 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.