Assessment of New Molecular Imaging Strategies for Prostate Cancer (MISTER)
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|ClinicalTrials.gov Identifier: NCT02813226|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Molecular Imaging||Not Applicable|
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 (MDP) bone scan and Computed Tomography (CT) of the abdomen and pelvis, and functional imaging with 18F-fluorodeoxyglucose (FDG) PET-CT and 2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid (18F-DCFPyL) PET-CT one to four weeks prior to hormonal treatment and approximately 10 weeks post hormonal treatment.
Prostate Specific Antigen (PSA) will also be obtained at baseline and every three months in the first year. Baseline imaging of disease and changes between baseline and follow-up imaging on 18F-FDG PET-CT and 18F-DCFPyL PET-CT will be compared with standard of care imaging (99mTc-MDP bone scan and CT of the abdomen/pelvis) as well as with clinical evaluation including response to therapy and progression of disease.
This information could be used by clinicians to guide androgen receptor (AR) - targeted therapy. Patients will have a clinical follow-up every 3 months post randomization for one year and will be followed for survival at Years 2 and 3.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of New Molecular Imaging Strategies for Prostate Cancer: Predictive Value of Established and Novel Positron Emission Tomography (PET) Radiotracers in Castration-Resistant Prostate Cancer|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||December 2020|
Other: Molecular Imaging
Baseline and follow-up FDG PET-CT and DCFPyL PET-CT
- Functional imaging metabolic response contrasted with conventional imaging response [ Time Frame: 10 weeks ]Percent change of the average maximum standardized uptake value (SUVmax) of target lesions in contrast with conventional imaging soft tissue and bone response between the baseline scans and the Week 10 scans.
- Functional imaging response [ Time Frame: 10 weeks ]The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.
- Radiological progression free survival. [ Time Frame: 3 years ]The time from registration to the first date of radiographic disease progression in bone or soft tissue or to the date of death
- Prostate specific antigen (PSA) response [ Time Frame: 3 years ]The time from registration to the date of PSA progression
- Progressive Disease (example change in treatment, skeletal related event) [ Time Frame: 3 years ]The time from registration to initiation of anti-cancer intervention or death from any cause.
- Overall Survival [ Time Frame: 3 years ]The time from registration to the date of death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813226
|Juravinski Hospital and Cancer Centre|
|Hamilton, Ontario, Canada|
|London Health Sciences Centre|
|London, Ontario, Canada|
|Sunnybrook-Odette Cancer Centre|
|Toronto, Ontario, Canada|
|Principal Investigator:||Katherine Zukotynski||Hamilton Health Sciences Corporation|
|Principal Investigator:||Eric Winquist||London Health Sciences Centre|