Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: radium-223 dichloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radium-223<br> | Drug: radium-223 dichloride<br>* 6 doses of Radium-223<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV-max | fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSMA