Metastatic Castration-resistant Prostate Cancer
Conditions
Brief summary
Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.
Interventions
DRUGilluccix 68Ga-PSMA-11 Total Body PET-CT
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11
Sponsors
Telix Pharmaceuticals (Innovations) Pty Limited
BAMF Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Male ≥ 18 years of age 3. Patients meeting clinical need for Illuccix PET scan: 1. Patients with suspected metastasis who are candidates for initial definitive therapy 2. Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level 4. Patient is physically able to lay flat for the PET-CT procedure
Exclusion criteria
1\. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths. | 3 months | In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length. |
Countries
United States
Contacts
Primary ContactDan Rogers
Outcome results
None listed