Prostate CancerMISTERNCT02813226
Assessment of New Molecular Imaging Strategies for Prostate Cancer
A study testing Molecular Imaging in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 3 sites in Canada.
Trial 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 treatment and post treatment to determine if changes in imaging results will be prognostic of outcome. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Molecular Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesCanada
- Study dates
- 16 Feb 2017to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Juravinski Hospital and Cancer Centre
Hamilton, Ontario
London Health Sciences Centre
London, Ontario
Sunnybrook-Odette Cancer Centre
Toronto, Ontario
About this study
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
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 treatment and post treatment to determine if changes in imaging results will be prognostic of outcome. Patients will have a clinical follow-up every 3 months post randomization for one year and followed for survival at Years 2 and 3.
Read the 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 (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.
- Conditions
- Prostate Cancer
- Being tested
- Molecular Imaging
- Keywords
- castration-resistant, molecular imaging, abiraterone acetate, enzalutamide, metabolic response
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular ImagingOther
Baseline and follow-up FDG PET-CT and DCFPyL PET-CT
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Other | Molecular Imaging Receives: Other: Molecular Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional imaging metabolic response contrasted with conventional imaging response
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.
Measured: 10 weeks
Secondary outcomes (5)
Functional imaging response
The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.
Measured: 10 weeks
Radiological progression free survival.
The time from registration to the first date of radiographic disease progression in bone or soft tissue or to the date of death
Measured: 3 years
Prostate specific antigen (PSA) response
The time from registration to the date of PSA progression
Measured: 3 years
Progressive Disease (example change in treatment, skeletal related event)
The time from registration to initiation of anti-cancer intervention or death from any cause.
Measured: 3 years
Overall Survival
The time from registration to the date of death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start16 Feb 2017
- Primary completion20 Mar 2020
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Zukotynski, Principal investigator, Hamilton Health Sciences CorporationEric Winquist, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813226
- Sponsor's protocol ID
- OCOG-2016-MISTER
- Acronym
- MISTER
- Status last verified
- Dec 2021
- First submitted
- 22 Jun 2016
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02813226
- Acronym / sponsor ID
- MISTER / OCOG-2016-MISTER
- Conditions
- Prostate Cancer
- Keywords
- castration-resistant, molecular imaging, abiraterone acetate, enzalutamide, metabolic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatment and post treatment to determine if changes in imaging results will be prognostic of outcome. Patients will have a clinical follow-up every 3 months post randomization for one year and followed for survival at Years 2 and 3.
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 (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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | Other | Other: Molecular ImagingMolecular Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Objectively documented metastatic prostate cancer progression with either of the following:
- Ongoing androgen deprivation therapy with serum testosterone <50 ng/dL (<1.7 nmol/L).
- Planned to start abiraterone acetate or enzalutamide.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular ImagingBaseline and follow-up FDG PET-CT and DCFPyL PET-CT | Other | Imaging |
Primary outcome
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.
5 secondary outcomes
Functional imaging response
Time frame: 10 weeks
Radiological progression free survival.
Time frame: 3 years
Prostate specific antigen (PSA) response
Time frame: 3 years
Progressive Disease (example change in treatment, skeletal related event)
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Zukotynski principal investigator
Hamilton Health Sciences Corporation
Eric Winquist principal investigator
London Health Sciences Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular Imaging in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional imaging metabolic response contrasted with conventional imaging response (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.