This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04928820.
PRIMARY OBJECTIVE:
I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.
SECONDARY OBJECTIVES:
I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.
II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).
III. To compare the positive predictive value (PPV) per-patient in patients with available lesion validation (follow-up imaging or biopsy that may be performed as standard of care based on the treating physician's decision).
OUTLINE:
Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorJeremie Calais
