Find a Trial Find Expert Physicians 
News Trial Stats
Clinical TrialsFacts & Fears Who pays for it, placebos, being a guinea pig, and what taking part really means.Basics ofTheranostics A fundamental way of finding and treating your cancer, all in one.Basics ofRadiation What is radiation, and how can it benefit you? InterpretingYour Scans What CT, MRI and PET can and can’t tell you about cancer.What to Expect as aTheranostic Patient Scans, treatment day, and the precautions once you are home.Basics ofDosimetry How much radiation each organ and tumor actually absorbs.TheranosticDictionary Plain-language meanings for the vocabulary on your paperwork.
News Trial Stats
Contact XCancer®
Mon–Thu 8am–4:30pm CT · Fri 8am–3pm CT
Clinical Trial · NCT03768349
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Overview
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.
Sponsor
Mayo Clinic
Phase
Early Phase 1
Contacts
Val Lowe, M.D. (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03768349Drug / Compound
PSMA-11
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
PSMA-1007
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PSMA
Ligand Class: Small Molecules
Eligibility
Inclusion
- 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.
- Histopathological proven prostate adenocarcinoma.
Exclusion
- 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).
- 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).
- Undergoing investigational therapy for prostate cancer.
- Absence of PSA and total testosterone tests within 4 weeks.
- Unable to lie flat, still or tolerate a PET scan.
Share your feedback
Help us improve your experience