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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
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prostate Cancer focused on measuring PSMA

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
February 20, 2017
Last Updated
September 20, 2021
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
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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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