Prostate Adenocarcinoma Clinical Trial
Official title:
Gallium-68 PSMA-11 and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
This phase II trial studies how well gallium-68 PSMA-11 PET/CT works for the diagnosis of prostate cancer with rising PSA following prostatectomy or radiation therapy (biochemically recurrent). Gallium-68 PSMA-11 is a radioactive tracer. PET/CT scans reveal information about both the structure and function of cells and tissues in the body during a single imaging session using a radioactive compound. This trial is being done to see if gallium-68 PSMA-11 PET/CT scan works better in diagnosing prostate cancer compared to standard C-11 choline PET/CT scans.
PRIMARY OBJECTIVE:
I. Positive predictive value (PPV) on a per-patient basis of gallium Ga 68-labeled PSMA-11
(68Ga-PSMA-11) and carbon C 11 choline (C-11 choline) positron emission tomography (PET) for
detection of tumor location confirmed by histopathology/biopsy.
SECONDARY OBJECTIVES:
I. PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 and C-11 choline PET for
detection of tumor location confirmed by histopathology/biopsy or conventional imaging
follow-up.
II. Sensitivity and specificity on a per-patient and per-region basis of 68Ga-PSMA-11 and
C-11 choline PET for detection of tumor location confirmed by histopathology/biopsy and/or
conventional imaging follow-up.
III. Detection rates on a per-patient basis of 68Ga-PSMA-11 and C-11 choline 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 and C-11 choline PET on clinical management in BCR patients.
V. Inter-reader reproducibility. VI. Safety of 68Ga-PSMA-11, as characterized by Common
Terminology Criteria for Adverse Events (CTCAE) 4.03.
OUTLINE:
Patients receive 68Ga-PSMA-11 and C-11 choline intravenously (IV) and then undergo
PET/computed tomography (CT) imaging over 30 minutes.
After completion of study, patients are followed up at 1-3 days and then for 12 months.
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