Prostate CancerPhase 3Solar-StageNCT06235151
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
A Phase 3 study testing Copper Cu 64 PSMA I&T in people with Prostate Cancer and Prostate Adenocarcinoma, run by Curium US LLC at 43 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Copper Cu 64 PSMA I&T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 43 sitesUnited States
- Study dates
- 1 Apr 2024to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
VA Boston Healthcare System
Boston, Massachusetts, 02130
Urology of Indiana, LLC
Carmel, Indiana, 46032
UNC Cancer Center
Chapel Hill, North Carolina, 27514
Hollings Cancer Center
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
Providence Medical Foundation
Fullerton, California, 92835
United Theranostics
Glen Burnie, Maryland, 21061
Adaptive Research Inc.
Hawthorne, New York, 10532
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141
Urology Centers of Alabama
Homewood, Alabama, 35209
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
The University of Kansas Hospital
Kansas City, Kansas, 66160
Dayton Physicians Network / Greater Dayton Cancer Center
Kettering, Ohio, 45409
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Arkansas Urology
Little Rock, Arkansas, 72211
Tower Urology
Los Angeles, California, 90048
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
CIRA Health
Miami, Florida, 33165
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
Columbia University Medical Center
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Great Plains Health, Diagnostic Imaging
North Platte, Nebraska, 69101
XCancer
Omaha, Nebraska, 68130
University of California, Irvine
Orange, California, 92868
VA Portland Health Care System
Portland, Oregon, 97239
United Theranostics
Princeton, New Jersey, 08540
Urology San Antonio
San Antonio, Texas, 78229
The Urology Place
San Antonio, Texas, 78240
San Francisco VA Medical Center
San Francisco, California, 94121
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Providence Saint John's Health Center
Santa Monica, California, 90404
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104
John Cochran VA Medical Center
St Louis, Missouri, 63106
Stanford Hospital & Clinics
Stanford, California, 94305
Florida Urology Partners
Tampa, Florida, 33615
James J. Peters VA Medical Center
The Bronx, New York, 10468
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging 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
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.
Read the detailed description
The study will include approximately 439 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\&T injection.
The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of lesions considered positive for Prostate Cancer (PC) in pelvic lymph nodes. Positive lesions in the prostate, extra pelvic lymph nodes, bones and soft tissue/viscera will also be recorded. Analysis of the reads will be used for determination of sensitivity and specificity of copper Cu 64 PSMA I\&T PET/CT by comparison to the reference standard of histopathology after matching by hemipelvis with at least one true positive lesion defining a true positive patient. Detection of PC outside the pelvis on the copper Cu 64 PSMA I\&T PET/CT will be assessed using reference standard of histopathology and if not available conventional imaging. Baseline conventional imaging will be reviewed for PC disease or no disease by independent radiology readers.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Copper Cu 64 PSMA I&T
- Keywords
- PSMA, Prostate Cancer, Initial Staging, Solar-Stage, Cu-64 PSMA, PET, Solar
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Cu 64 PSMA I&TDrug
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Imaging with Copper Cu 64 PSMA I&T | Experimental | Copper Cu 64 PSMA I\&T Injection Receives: Drug: Copper Cu 64 PSMA I&T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Hours
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.
Measured: 4 Hours
Secondary outcomes (3)
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.
Measured: 4 Hours
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.
Measured: At time of dose administration up to 72 Hours
Positive Predictive Value and Negative Predictive Value
- To assess the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of copper Cu 64 PSMA I\&T PET/CT
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Apr 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 439 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curium US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235151
- Sponsor's protocol ID
- CURCu64PSM0003
- Acronym
- Solar-Stage
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging 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
- ClinicalTrials.gov ID
- NCT06235151
- Acronym / sponsor ID
- Solar-Stage / CURCu64PSM0003
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- PSMA, Prostate Cancer, Initial Staging, Solar-Stage, Cu-64 PSMA, PET, Solar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 439 participants (estimated)
- Lead sponsor
- Curium US LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will include approximately 439 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\&T injection.
The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of lesions considered positive for Prostate Cancer (PC) in pelvic lymph nodes. Positive lesions in the prostate, extra pelvic lymph nodes, bones and soft tissue/viscera will also be recorded. Analysis of the reads will be used for determination of sensitivity and specificity of copper Cu 64 PSMA I\&T PET/CT by comparison to the reference standard of histopathology after matching by hemipelvis with at least one true positive lesion defining a true positive patient. Detection of PC outside the pelvis on the copper Cu 64 PSMA I\&T PET/CT will be assessed using reference standard of histopathology and if not available conventional imaging. Baseline conventional imaging will be reviewed for PC disease or no disease by independent radiology readers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Imaging with Copper Cu 64 PSMA I&T | Experimental | Drug: Copper Cu 64 PSMA I&TCopper Cu 64 PSMA I\&T Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper Cu 64 PSMA I&TRadiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer. | Drug | Diagnostic Imaging with Copper Cu 64 PSMA I&T |
Primary outcome
Sensitivity
Time frame: 4 Hours
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.
Specificity
Time frame: 4 Hours
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.
3 secondary outcomes
Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis
Time frame: 4 Hours
Incidence of adverse events in copper Cu 64 PSMA I&T injection
Time frame: At time of dose administration up to 72 Hours
Positive Predictive Value and Negative Predictive Value
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Copper Cu 64 PSMA I&T in people with Prostate Cancer and Prostate Adenocarcinoma, run by Curium US LLC at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 4 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.