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

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: radium-223 dichloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03062254

17-029

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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