Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Completed · Phase 2/Phase 3
Conditions studied: Prostate Cancer
In brief
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Key facts
- Study ID
- NCT02918357
- Run by
- University of California, San Francisco
- People needed
- 385
- Starts
- 2016-09-15
- Expected to finish
- 2017-09-21
- Last updated by the study team
- 2019-12-02
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histopathological proven prostate adenocarcinoma.
- Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
- PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
- Confirmatory persistent PSA greater than 0.2 ng/mL
- Post-radiation therapy -ASTRO-Phoenix consensus definition
- Nadir + greater than or equal to 2 ng/mL rise in PSA
- Karnofsky performance status of greater than 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.
You may not qualify if…
- Investigational therapy for prostate cancer.
- 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).
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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