A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Curium US LLC
- Enrollment
- 150
- Locations
- 29
- Primary Endpoint
- 1. The sensitivity of copper Cu 64 PSMA I&T PET/CT to determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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 ≥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 PC prior to prostatectomy.
- •Patients participating in an interventional clinical trial within 30 days and having received an IP within five (5) biological half-lives prior to administration.
- •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.
- •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 (>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 as part of their standard medical care within 90 days prior to enrollment
Outcomes
Primary Outcomes
1. The sensitivity of copper Cu 64 PSMA I&T PET/CT to determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.
1. The sensitivity of copper Cu 64 PSMA I&T PET/CT to determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.
2. The specificity of copper Cu 64 PSMA I&T PET/CT to determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.
2. The specificity of copper Cu 64 PSMA I&T PET/CT to determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.
Secondary Outcomes
- 1. Reader kappa statistics of copper Cu 64 PSMA I&T PET/CT scan interpretation by the blinded independent readers.
- 2. Treatment-emergent adverse events from the time of IP administration up to 72 hours.
Investigators
Anni Morsing, Curium Denmark
Scientific
Curium US LLC