Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
radium-223 dichloride
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer focused on measuring PSMA
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
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radium-223
Arm Description
Outcomes
Primary Outcome Measures
SUV-max
fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT
Secondary Outcome Measures
Full Information
NCT ID
NCT03062254
First Posted
February 20, 2017
Last Updated
September 20, 2021
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03062254
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PSMA
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radium-223
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
radium-223 dichloride
Intervention Description
6 doses of Radium-223
Primary Outcome Measure Information:
Title
SUV-max
Description
fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT
Time Frame
6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy
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