Clareo Health | 68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy
68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jonsson Comprehensive Cancer Center
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 lesion validation (follow-up imaging or biopsy).
OUTLINE:
Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen \[PSA\] level \>= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)
Patients with bone scan scheduled or performed
* Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
Patients or their legal representatives must have the ability to read, understand and provide written informed consent
You may not be if
Initiation of a new therapy between the PSMA PET/CT and the bone scans
Inability to provide written informed consent
Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
