Prostate Cancer
Conditions
Keywords
Prostate Cancer, PET/CT, PSMA, C-11 Choline
Brief summary
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
Interventions
DRUGGa-68 PSMA11
Ga-68 PSMA11 PET/CT for detection of tumor location
DRUGF-18 PSMA 1007
F-18 PSMA 1007 PET/CT for detection of tumor location
Sponsors
Mayo Clinic
Study design
Allocation
NON_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. Histopathological proven prostate adenocarcinoma. 2. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. \> 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies) 3. Karnofsky performance status of 50 (or ECOG/WHO equivalent). 4. CT or as part of the PET study or performed within one month of PSMA PET. 5. Age \> 18. 6. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
1. Undergoing investigational therapy for prostate cancer. 2. Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects). 3. Unable to lie flat, still or tolerate a PET scan. 4. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. 5. Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Detection on PET/CT | 12 Months post PET/CT | Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of PSMA and C-11 choline PET on clinical management | 12 Months | Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management |
| Incidence of adverse events attributable to PSMA | 12 Months | Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) |
Countries
United States
Outcome results
None listed