Status:
COMPLETED
Assessment of New Molecular Imaging Strategies for Prostate Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC) planned to have hormonal treatment, will undergo conventional imaging and functional imaging prior to treatme...
Detailed Description
In this study 30 men, with advanced metastatic CRPC intended to have abiraterone acetate or enzalutamide hormonal treatment will undergo conventional imaging including a 99mTc-Methyl diphosphonate (MD...
Eligibility Criteria
Inclusion
- Objectively documented metastatic prostate cancer progression with either of the following:
- At least one rising PSA over a minimum of one week interval within six weeks of study registration, or
- Radiographic progression in soft tissue and/or bone within six weeks of study registration
- Ongoing androgen deprivation therapy with serum testosterone \<50 ng/dL (\<1.7 nmol/L).
- Planned to start abiraterone acetate or enzalutamide.
Exclusion
- Age \< 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \>2.
- Planned to receive palliative radiotherapy within the next 12 weeks.
- Hemoglobin \< 90 g/L independent of transfusion.
- Platelet count \< 50 x 10\^9 / L.
- Serum albumin \< 30 g/L.
- Serum creatinine \> 1.5 x Upper Limit of Normal (ULN) or a calculated creatinine clearance \<30 L/min.
- Contraindications to FDG.
- Inability to lie supine for imaging with PET-CT.
- Inability to undergo CT due to known allergy to contrast.
- Inadequate hepatic function: (i) Bilirubin \>1.5 x ULN, and (ii) Serum glutamic oxaloacetic transaminase (SGOT) \>3 x ULN
- Inability to complete the study or required follow-up
Key Trial Info
Start Date :
February 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02813226
Start Date
February 16 2017
End Date
December 17 2021
Last Update
December 21 2021
Active Locations (3)
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1
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
2
London Health Sciences Centre
London, Ontario, Canada
3
Sunnybrook-Odette Cancer Centre
Toronto, Ontario, Canada