Gallium-68 PSMA-11 and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:January 3, 2019
End Date:December 1, 2021

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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) in
order to demonstrate their utility in detecting prostate cancer.


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 exclusion criteria can be removed
if Furosemide is omitted as part of the PET imaging protocol if a second-generation
scatter correction is available for the used PET device).

6. Absence of PSA and total testosterone tests within 4 weeks.
We found this trial at
1
site
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
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