Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorCurium US LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Copper Cu 64 PSMA I&T
DrugRadiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Treatment groups
439 Participants
are divided into 1 treatment groupGroup A: Diagnostic Imaging with Copper Cu 64 PSMA I&TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity
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.
Time frame
4 Hours2
Specificity
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.
Time frame
4 HoursSecondary outcomes
1
Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis
Reader kappa statistics of copper Cu 64 PSMA I\&T PET/CT scan interpretation by the blinded independent readers.
Time frame
4 Hours2
Incidence of adverse events in copper Cu 64 PSMA I&T injection
Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
At time of dose administration up to 72 Hours3
Positive Predictive Value and Negative Predictive Value
1\. To assess the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of copper Cu 64 PSMA I\&T PET/CT
Time frame
4 hoursOther outcomes
1
Determine the relationship of Prostate Specific Antigen (PSA) level, Gleason score, and the diagnostic performance of copper Cu 64 PSMA I&T PET/CT
Correlation of sensitivity, specificity, detection rate, and Positive Predictive Value (PPV) to baseline PSA and unfavorable intermediate-risk, high-risk or very high-risk at the time of prostatectomy.
Time frame
4 Hours2
Assess PPV of lesions on copper Cu 64 PSMA I&T PET/CT outside the prostate and pelvic lymph nodes (M1 disease)
Proportion of patients with M1 lesions on copper Cu 64 PSMA I\&T PET/CT subsequently confirmed to be TP by biopsy, surgery and confirmatory imaging.
Time frame
4 Hours3
Assess the impact of copper Cu 64 PSMA I&T PET/CT on the intended clinical management of study participants
Percentage of patients in whom the copper Cu 64 PSMA I\&T PET/CT changed the intended patient management (major and other changes).
Time frame
4 Hours4
Assess the detection rate on patient level and split by pelvic lymph nodes and extra pelvic lesions
Patient level positivity rates of copper Cu 64 PSMA I\&T split by pelvic lymph nodes and extra pelvic lesions.
Time frame
4 HoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov