Metastasis From Malignant Tumor of Prostate (Disorder)Phase 2NCT05653856
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
A Phase 2 study testing 64Cu-PSMA I&T in people with Metastasis From Malignant Tumor of Prostate (Disorder), run by Curium US LLC at 9 sites in United States.
Trial summary
This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastasis From Malignant Tumor of Prostate (Disorder)
- What is being tested?
- 64Cu-PSMA I&T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Dec 2022to 17 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Prior radical prostatectomy or radiation therapy with curative intent.
- Recurrence of disease defined as:
- Prior Radical Prostatectomy: PSA > 0.2 ng/mL, or
- Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
- Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
- Age greater than or equal to 18 years.
- Able to understand and provide signed written informed consent.
Who cannot join
- Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
- Body weight greater than 350 lb (158 kg).
- Investigational therapy within the past 30 days.
- Creatinine clearance (ClCr) less than 30 mL/min.
- Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141
MD Anderson
Houston, Texas, 77030
Yale University
New Haven, Connecticut, 06520
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
XCancer Omaha/Urology Cancer Center
Omaha, Nebraska, 68130
Saint Louis University
St Louis, Missouri, 63104
John J. Cochran Veterans Hospital
St Louis, Missouri, 63106
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Multi-Center, Open-Label, Randomized Phase 2 Study of Copper Cu 64 PSMA I&T Injection in Patients With Histologically Proven Metastatic Prostate Cancer
This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
Read the detailed description
The study will include a group of 26 patients with metastatic prostate cancer. Each patient will be administered a 7-9 mCi intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT images will be acquired for all patients at 1 hour ± 15 minutes and 4 hours ± 30 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 prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T in each of the four regions: 1) prostate bed or prostate gland, 2) lymph nodes (pelvic and extra pelvic), 3) bone, and 4) viscera/soft tissue. Analysis of the reads will be used for determination of the CLR and CDR for 1 hour and 4-hour post-injection imaging of copper Cu 64 PSMA I\&T PET/CT by comparison to the Composite Reference Standard.
- Being tested
- 64Cu-PSMA I&T
- Keywords
- PSMA, Prostate Cancer, PET, SOLAR, Cu-64 PSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-PSMA I&TDrug
Radiolabeled Receptor-Targeted Diagnostic Product
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Imaging with 64Cu-PSMA-I&T | Experimental | 64Cu-PSMA I\&T Receives: Drug: 64Cu-PSMA I&T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Region-Level Correct Localization Rate (CLR)
To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.
Measured: 4 Hours
Patient-Level Correct Detection Rate (CDR)
To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.
Measured: 4 Hours
Incidence of Adverse Events
Adverse events (AEs) were assessed from the time of copper Cu 64 PSMA I\&T injection throughout the24-hour assessment period. AEs were assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 24 Hours
Secondary outcomes (1)
Score of Image Quality
To compare the diagnostic quality of PET/CT images obtained at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection. Image quality score is based on a scale of 0-2 where 0 is not of diagnostic quality and 2 is of best diagnostic quality.
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 posted16 Dec 2022
- Study start5 Dec 2022
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastasis From Malignant Tumor of Prostate (Disorder)Studies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curium US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653856
- Sponsor's protocol ID
- CURCu64PSM0001 (Phase II)
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2022
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Randomized Phase 2 Study of Copper Cu 64 PSMA I&T Injection in Patients With Histologically Proven Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT05653856
- Acronym / sponsor ID
- CURCu64PSM0001 (Phase II)
- Keywords
- PSMA, Prostate Cancer, PET, SOLAR, Cu-64 PSMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Curium US LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Posted 24 Jan 2025
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 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
Detailed description
The study will include a group of 26 patients with metastatic prostate cancer. Each patient will be administered a 7-9 mCi intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT images will be acquired for all patients at 1 hour ± 15 minutes and 4 hours ± 30 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 prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T in each of the four regions: 1) prostate bed or prostate gland, 2) lymph nodes (pelvic and extra pelvic), 3) bone, and 4) viscera/soft tissue. Analysis of the reads will be used for determination of the CLR and CDR for 1 hour and 4-hour post-injection imaging of copper Cu 64 PSMA I\&T PET/CT by comparison to the Composite Reference Standard.
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 64Cu-PSMA-I&T | Experimental | Drug: 64Cu-PSMA I&T64Cu-PSMA I\&T |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically proven prostate adenocarcinoma.
- Prior radical prostatectomy or radiation therapy with curative intent.
- Recurrence of disease defined as:
- Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
- Age greater than or equal to 18 years.
Key exclusion criteria (5 listed)
- Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
- Body weight greater than 350 lb (158 kg).
- Investigational therapy within the past 30 days.
- Creatinine clearance (ClCr) less than 30 mL/min.
- Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.
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 |
|---|---|---|
| 64Cu-PSMA I&TRadiolabeled Receptor-Targeted Diagnostic Product | Drug | Diagnostic Imaging with 64Cu-PSMA-I&T |
Primary outcome
Region-Level Correct Localization Rate (CLR)
Time frame: 4 Hours
To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.
Patient-Level Correct Detection Rate (CDR)
Time frame: 4 Hours
To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.
Incidence of Adverse Events
Time frame: 24 Hours
Adverse events (AEs) were assessed from the time of copper Cu 64 PSMA I\&T injection throughout the24-hour assessment period. AEs were assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
1 secondary outcome
Score of Image Quality
Time frame: 4 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 64Cu-PSMA I&T in people with Metastasis From Malignant Tumor of Prostate (Disorder), run by Curium US LLC at 9 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Region-Level Correct Localization Rate (CLR) (time frame: 4 Hours). The study lists 3 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 24 Jan 2025.