Prostate Cancer
Conditions
Keywords
PSMA
Brief summary
Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.
Interventions
6 doses of Radium-223
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Resident of Canada * Male sex * Age 18 years or older * Progressive (symptoms, conventional imaging, PSA, bone scan, FCH PET/CT or other) castration-resistant prostate cancer in the judgment of the treating physician without change in systemic anti-neoplastic therapy since documented progression * Six or greater bone metastases robustly-avid on recent (4 weeks) MDP or NaF scintigraphy * Recently failed (within 3 months) or failing novel androgen receptor pathway inhibitors (abiraterone + prednisone or enzalutamide) with intention of continuing the drug for at least 7 months OR minimum 14 day washout period from either agent prior to study enrollment * No known visceral metastases or adenopathy greater than 3 cm short axis on conventional imaging * Not received docetaxel for castration-resistant disease * ECOG performance status 0 - 2, inclusive * Life expectancy of greater than 6 months * Serum testosterone less than or equal to 50 ng/dl * Hemoglobin greater than or equal to 100 g/L with no blood transfusions or EPO in preceding 3 weeks * Neutrophils greater than or equal to 1.5 x109/L * Platelets greater than or equal to 100 x109/L * No prior hemi-body radiotherapy * No impending or established spinal cord compression * No unmanageable fecal incontinence * Patient has good IV access * Able to understand and provide written informed consent
Exclusion criteria
* Planned change in systemic anti-neoplastic therapy during the approximately 7 month trial * Unable to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 30 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug. * Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.) * Patients who exceed the safe weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (70 cm diameter) * Patients who are claustrophobic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUV-max | 6 months | fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT |
Countries
Canada
Outcome results
None listed