Status:
COMPLETED
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
Lead Sponsor:
Thomas Hope
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 rec...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histopathologically proven prostate adenocarcinoma.
- Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy
- PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
- 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
- Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Age \>= 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Exclusion Criteria
- Unable to lie flat, still or tolerate a PET scan.
- Concomitant investigational therapy.
- 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.
- 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).
Exclusion
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT03353740
Start Date
September 20 2017
End Date
September 1 2020
Last Update
October 21 2021
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143