Gallium Ga 68-labeled PSMA-11 PET / CT in Detecting Recurrent Prostate Cancer in Patients after Initial Therapy
This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET) / computed tomography (CT) works in detecting prostate cancer that has come back in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / CT, may help doctors detect tumors that have come back after initial therapy.
- Histopathological proven prostate adenocarcinoma
- Rising PSA after definitive therapy with prostatectomy or radiation therapy. * Post radical prostatectomy (RP) ** PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP * Post-radiation therapy – American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition ** 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)
- Ability to understand a written informed consent document, and the willingness to sign it
- Concomitant investigational therapy
- Unable to lie flat, still or tolerate a PET scan
- 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
Locations & Contacts
Contact: Johannes Czernin
Trial Objectives and Outline
I. To evaluate gallium Ga 68-labeled PSMA-11 PET whole body imaging for detection of disease recurrence in clinically relevant anatomic regions.
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.
After completion of study, patients are followed up for 3-12 months.
Trial Phase & Type
UCLA / Jonsson Comprehensive Cancer Center
Secondary IDs NCI-2016-01212
Clinicaltrials.gov ID NCT02940262