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Effect of Copper CU64 PSMA I&T scanning to detect potential disease spread to lymph nodes in men with newly diagnosed Prostate Cancer
EU CTIS ID: 2024-512754-16-01
What this study is testing
Primary Objective and Endpoints To determine the diagnostic performance of copper Cu 64 PSMA I&T PET/CT for the detection of presence or absence of pelvic lymph node metastasis in pre-prostatectomy patients with unfavorable intermediate-risk, high-risk or very high-risk PC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients with histologically proven prostate adenocarcinoma.
- 2. Planned prostatectomy with pelvic lymph node dissection.
- 3. Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
- 4. Male aged ≥18 years.
- 5. Able to understand and provide signed written informed consent.
You likely can't join if
- 1. Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against PC prior to prostatectomy.
- 2. Patients participating in an interventional clinical trial within 30 days and having received an IP within five (5) biological half-lives prior to administration.
- 3. Patients with any medical condition or circumstance (including receiving an IP or capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- 4. 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.
- 5. Patients who are administered any high energy (>300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&T administration.
- 6. Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
See the full eligibility criteria
- 1. Patients with histologically proven prostate adenocarcinoma.
- 2. Planned prostatectomy with pelvic lymph node dissection.
- 3. Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
- 4. Male aged ≥18 years.
- 5. Able to understand and provide signed written informed consent.
- 1. Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against PC prior to prostatectomy.
- 2. Patients participating in an interventional clinical trial within 30 days and having received an IP within five (5) biological half-lives prior to administration.
- 3. Patients with any medical condition or circumstance (including receiving an IP or capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- 4. 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.
- 5. Patients who are administered any high energy (>300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&T administration.
- 6. Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
- 7. Patients who had a PSMA PET 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
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.