Clinical trial NCT05653856: Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastasis From Malignant Tumor of Prostate (Disorder)
Keywords: PSMA
Prostate Cancer
PET
SOLAR
Cu-64 PSMA
Lead sponsor: Curium US LLC
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically proven prostate adenocarcinoma.
2. Prior radical prostatectomy or radiation therapy with curative intent.
3. Recurrence of disease defined as:

   1. Prior Radical Prostatectomy: PSA \> 0.2 ng/mL, or
   2. Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
4. Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
5. Age greater than or equal to 18 years.
6. Able to understand and provide signed written informed consent.

Exclusion Criteria:

1. Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
2. Body weight greater than 350 lb (158 kg).
3. Investigational therapy within the past 30 days.
4. Creatinine clearance (ClCr) less than 30 mL/min.
5. Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.

Primary outcomes:
measure: Region-Level Correct Localization Rate (CLR)
timeFrame: 4 Hours
measure: Patient-Level Correct Detection Rate (CDR)
timeFrame: 4 Hours
measure: Incidence of Adverse Events
timeFrame: 24 Hours
Secondary outcomes:
measure: Score of Image Quality
timeFrame: 4 Hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: John J. Cochran Veterans Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: XCancer Omaha/Urology Cancer Center
state: Nebraska
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
References: