Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
PSMA, Biochemically Recurrent Prostate Cancer
Brief summary
The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.
Detailed description
Participants (male veterans) with initial diagnosis of prostate cancer or biochemically recurrent disease that consent to participate in the study will receive both conventional imaging (MRI, CT, and/or molecular imaging bone scan) as well as Ga-68-PSMA-11 PET/CT. Following baseline assessment (Visit #1), Ga-68-PSMA-11 (3-7 mCi) will be administered as a single intravenous administration with PET/CT performed approximately 60 minutes after injection (Visit #2A). At approximately 120 minutes after injection of Ga-68-PSMA-11, the final evaluation for safety and tolerability will occur (Visit #2B)
Interventions
DRUGGa-68-PSMA-11
Ga-68-PSMA-11 is produced via a lyophilized Sterile Cold kit. Ga-68 is eluted from a Ge-68/Ga-68 generator into a vial containing the premixed peptide and buffer. PSMA-11 radiolabeled with Ga-68 is administered to patients following verification of standard quality controls including activity measurement, pH, radiochemical purity, and visual inspection
Sponsors
Harry S. Truman Memorial Veterans' Hospital
University of Missouri-Columbia
Telix Pharmaceuticals, Ltd
Timothy Hoffman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All eligible and consenting participants (male veterans) will receive a single administration of 3-7mCi Ga-68-PSMA-11 per enrollment in addition to conventional imaging (MRI, CT, and/or molecular imaging bone scan).
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to tolerate PET/CT imaging and one or more of the following: * Patients with newly diagnosed prostate cancer with primary staging classified at high/intermediate risk per NCCN guidelines OR * Biochemical Recurrence: Patients with rising PSA after definitive therapy with prostatectomy or radiation therapy or other local therapies
Exclusion criteria
* Claustrophobia or any other condition that would preclude PET/CT imaging. * Any constellation of medical conditions that indicate expectancy of less than one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concurrence with Conventional Imaging | Up to 28 days | Localized vs extra-pelvic recurrence will be determined for each patient based on Ga-68-PSMA-11 PET/CT and standard-of-care radiological imaging |
Countries
United States
Outcome results
None listed