Gallium Ga 68-labeled PSMA-11 PET / CT or PET / MRI in Diagnosing Patients with Biomedical Recurrent Prostate Cancer
This phase III trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET) / computed tomography (CT) or PET / magnetic resonance imaging (MRI) works in diagnosing patients with prostate cancer and with rising prostate specific antigen after treatment. Ga-68 PSMA is an imaging drug that binds to prostate tumor cells and can be imaged using PET. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / CT or PET / MRI, may help find the presence of prostate cancer.
- Histopathologically proven prostate adenocarcinoma
- Rising 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–American Society for Radiation Oncology (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)
- Ability to understand a written informed consent document, and the willingness to sign it
- 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)
Locations & Contacts
Contact: Thomas Hope
Trial Objectives and Outline
I. Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
I. Positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
II. Sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
III. Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0).
IV. Impact of 68Ga-PSMA-11 PET on clinical management in BCR patients.
V. Inter-reader reproducibility.
VI. Safety, as characterized by Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. Within 50-100 minutes, patients undergo PET/CT over 30-40 minutes or PET/MRI over 50-60 minutes.
After completion of study, patients are followed up at day 1 and then up to 12 months.
Trial Phase & Type
UCSF Medical Center-Mount Zion
Secondary IDs NCI-2018-00040, 15-17570
Clinicaltrials.gov ID NCT03353740