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Clinical Trial · NCT03353740
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
Overview
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Sponsor
University of California, San Francisco
Phase
Phase 3
Contacts
Thomas Hope, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03353740Drug / 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
Linker: Ahx
Eligibility
Inclusion
- Concomitant investigational therapy.
- Unable to lie flat, still or tolerate a PET scan.
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy
- 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).
- Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy
- Nadir + greater than or equal to 2 ng/mL rise in PSA
- Inclusion Criteria
- Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Histopathologically proven prostate adenocarcinoma.
- Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
Exclusion
Exclusion criteria not yet provided.
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