Status:
COMPLETED
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
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 Gall...
Eligibility Criteria
Inclusion
- Histopathological proven prostate adenocarcinoma.
- 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)
- Karnofsky performance status of 50 (or ECOG/WHO equivalent).
- CT or as part of the PET study or performed within one month of PSMA PET.
- Age \> 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion
- Undergoing investigational therapy for prostate cancer.
- 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).
- Unable to lie flat, still or tolerate a PET scan.
- 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.
- 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).
- Absence of PSA and total testosterone tests within 4 weeks.
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2021
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03768349
Start Date
January 3 2019
End Date
July 21 2021
Last Update
April 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905