Clinical trial NCT03062254: Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy
Official title: Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: PSMA
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: SUV-max
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: