Prostate CancerNCT02121600
18F-FCH PET/MRI to Assess Tumor Response in Castration Resistant Prostate Cancer
A study testing [F-18]-FCH, PET scan and MRI scan in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
Trial summary
Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess response to treatment in men with castration resistant prostate cancer (CRPC). It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack… 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?
- [F-18]-FCH, PET scan and MRI scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2014to Mar 2018
- 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
- 18 years of age or older
- Patient with CRPC and experiencing disease progression as defined by PCWG2
- ECOG 0-2
- Must continue gonadal castrative therapy
- Has completed antiandrogen withdrawal ≥ 6 weeks prior to registration
- Metastatic disease documented by imaging
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- Patient is planned for treatment with docetaxel or abiraterone
- If treated with bisphosphonates or denosumab, has been on these for ≥ 6 weeks.
- Must provide written informed consent
Who cannot join
- Prior history of invasive malignant disease unless disease free for at least 5 years, with the exception of non-melanoma skin cancer
- Planned for any concurrent anticancer treatment oher than docetaxel or abiraterone
- Prior radiotherapy or surgery within 4 weeks of start of docetaxel or abiraterone
- Inability to comply with the imaging requirements (eg. inability to lie supine for one hour)
- Allergy to MRI contrast agent or PET tracer to be used as part of the imaging
- Sickle cell disease or other hemoglobinopathies
Show all 11Show fewer
- Insufficient renal function (eGFR ≤ 30 mL/min)
- Known residual bladder volume > 150 cc
- Hip prosthesis or intrabdominal vascular grafting
- Contraindication to CT contrast
- Contraindication to MRI as per institutional policy
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Regional Cancer Program
London, Ontario, N6A 4L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: Assessment of CRPC Response Through Comprehensive Characterization Using Novel Biomarkers (PET CRPC)
Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess response to treatment in men with castration resistant prostate cancer (CRPC).
It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack thereof) earlier in the treatment period, providing a better guide for treating men with CRPC.
Read the detailed description
Castrate resistant prostate cancer (CRPC) occurs when prostate cancer no longer responds to androgen deprivation therapy. Eventually all men diagnosed with CRPC will succumb to their disease. While many new therapies have been introduced, there are limitations in assessing treatment response and physicians are faced with a challenge when creating a management strategy for men with CRPC.
Most men present with bone metastases, and accurate quantification of disease burden can be difficult due to the nature of conventional scans such as CT and bone scan. In addition, the standard blood PSA measurement does not always reflect a clinical response, or may lag to show this response. There is a clear need for better imaging and blood biomarkers to measure disease in men with CRPC.
This study will explore the benefit of a 18F-FCH Hybrid PET/MRI scan, Cancer Microparticle (CMP) and Circulating Tumor Cell (CTC) measurements compared to standard imaging and PSA levels.
In this study, patients will receive a 18F-FCH PET/MRI or 18F-FCH PET/CT scan + whole body MRI at baseline and after 12 weeks of treatment. Serial CMP and CTC blood samples will be taken at 5 study timepoints.
66 patients will be enrolled at 3 cancer centres in Ontario. Patients will be divided into 2 cohorts based on the type of treatment they will receive: Docetaxel or Abiraterone.
It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack thereof) earlier in the treatment period thus providing a better guide for treating men with CRPC.
- Conditions
- Prostate Cancer
- Being tested
- [F-18]-FCH, PET scan, MRI scan
- Keywords
- Fluorocholine (FCH), Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]-FCHOther
Also called [F-18]-Fluorocholine Injection
Before the PET/MRI or PET/CT scan, patients will receive an [F-18]-Fluorocholine injection in the arm.
PET scanRadiation
A whole body PET scan will be performed, combined with either whole body MRI or CT scan. This will be performed at baseline and after 12 weeks of treatment
MRI scanRadiation
Whole body MRI scan will be performed. This may be combined with PET scan or may be performed separately. MRI scan will be done at baseline and after 12 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Other | Patients who will be receiving Docetaxel as cancer treatment will be assigned to Arm 1. All patients in this cohort will have a [F-18]-FCH PET scan with full body MRI scan Receives: Other: [F-18]-FCH; Radiation: PET scan; Radiation: MRI scan |
| Abiraterone | Other | Patients who will be receiving Abiraterone as cancer treatment will be assigned to Arm 2. All patients in this cohort will have a [F-18]-FCH PET scan with full body MRI scan. Receives: Other: [F-18]-FCH; Radiation: PET scan; Radiation: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lesions detected with 18F-FCH PET/MRI compared to conventional imaging
Measured: 3 years
Secondary outcomes (5)
Number of concordant lesions identified on identified on 18F-FCH PET, conventional imaging and MRI
Measured: 3 years
Concordance between number Circulating Tumor Cells (CTCs) and Cancer Microparticles (CMPs) and number of lesions detected by PET/MRI and conventional imaging
At both baseline and after 12 weeks of treatment
Measured: 3 years
Change in number and size of lesions after 12 weeks of treatment
As detected by 18F-FCH PET/MRI and change in CTC and CMP values
Measured: 3 years
Progression Free Survival
Changes in lesion parameters on PET and MRI and changes in serial CTC and CMP levels will be assessed to see if they are predictive of progression free survival
Measured: 6 years
Overall Survival
Changes in lesion parameters on PET and MRI and changes in serial CTC and CMP levels will be assessed to see if they are predictive of overall survival
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2017
- Study completionMar 2018
Why it stopped: Low accrual
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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Eric Winquist, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121600
- Sponsor's protocol ID
- PET CRPC
- Status last verified
- May 2019
- First submitted
- 15 Apr 2014
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of CRPC Response Through Comprehensive Characterization Using Novel Biomarkers (PET CRPC)
- ClinicalTrials.gov ID
- NCT02121600
- Acronym / sponsor ID
- PET CRPC
- Conditions
- Prostate Cancer
- Keywords
- Fluorocholine (FCH), Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research
- Study start
- Sep 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Apr 2014 (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.
Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess response to treatment in men with castration resistant prostate cancer (CRPC).
It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack thereof) earlier in the treatment period, providing a better guide for treating men with CRPC.
Detailed description
Castrate resistant prostate cancer (CRPC) occurs when prostate cancer no longer responds to androgen deprivation therapy. Eventually all men diagnosed with CRPC will succumb to their disease. While many new therapies have been introduced, there are limitations in assessing treatment response and physicians are faced with a challenge when creating a management strategy for men with CRPC.
Most men present with bone metastases, and accurate quantification of disease burden can be difficult due to the nature of conventional scans such as CT and bone scan. In addition, the standard blood PSA measurement does not always reflect a clinical response, or may lag to show this response. There is a clear need for better imaging and blood biomarkers to measure disease in men with CRPC.
This study will explore the benefit of a 18F-FCH Hybrid PET/MRI scan, Cancer Microparticle (CMP) and Circulating Tumor Cell (CTC) measurements compared to standard imaging and PSA levels.
In this study, patients will receive a 18F-FCH PET/MRI or 18F-FCH PET/CT scan + whole body MRI at baseline and after 12 weeks of treatment. Serial CMP and CTC blood samples will be taken at 5 study timepoints.
66 patients will be enrolled at 3 cancer centres in Ontario. Patients will be divided into 2 cohorts based on the type of treatment they will receive: Docetaxel or Abiraterone.
It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack thereof) earlier in the treatment period thus providing a better guide for treating men with CRPC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Other | Other: [F-18]-FCH, Radiation: PET scan, Radiation: MRI scanPatients who will be receiving Docetaxel as cancer treatment will be assigned to Arm 1. All patients in this cohort will have a [F-18]-FCH PET scan with full body MRI scan |
| Abiraterone | Other | Other: [F-18]-FCH, Radiation: PET scan, Radiation: MRI scanPatients who will be receiving Abiraterone as cancer treatment will be assigned to Arm 2. All patients in this cohort will have a [F-18]-FCH PET scan with full body MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Patient with CRPC and experiencing disease progression as defined by PCWG2
- ECOG 0-2
- Must continue gonadal castrative therapy
- Has completed antiandrogen withdrawal ≥ 6 weeks prior to registration
Key exclusion criteria (11 listed)
- Prior history of invasive malignant disease unless disease free for at least 5 years, with the exception of non-melanoma skin cancer
- Planned for any concurrent anticancer treatment oher than docetaxel or abiraterone
- Prior radiotherapy or surgery within 4 weeks of start of docetaxel or abiraterone
- Inability to comply with the imaging requirements (eg. inability to lie supine for one hour)
- Allergy to MRI contrast agent or PET tracer to be used as part of the imaging
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 |
|---|---|---|
| [F-18]-FCHAlso: [F-18]-Fluorocholine InjectionBefore the PET/MRI or PET/CT scan, patients will receive an [F-18]-Fluorocholine injection in the arm. | Other | Abiraterone, Docetaxel |
| PET scanA whole body PET scan will be performed, combined with either whole body MRI or CT scan. This will be performed at baseline and after 12 weeks of treatment | Radiation | Abiraterone, Docetaxel |
| MRI scanWhole body MRI scan will be performed. This may be combined with PET scan or may be performed separately. MRI scan will be done at baseline and after 12 weeks of treatment | Radiation | Abiraterone, Docetaxel |
Primary outcome
Number of lesions detected with 18F-FCH PET/MRI compared to conventional imaging
Time frame: 3 years
5 secondary outcomes
Number of concordant lesions identified on identified on 18F-FCH PET, conventional imaging and MRI
Time frame: 3 years
Concordance between number Circulating Tumor Cells (CTCs) and Cancer Microparticles (CMPs) and number of lesions detected by PET/MRI and conventional imaging
Time frame: 3 years
Change in number and size of lesions after 12 weeks of treatment
Time frame: 3 years
Progression Free Survival
Time frame: 6 years
Overall Survival
Time frame: 6 years
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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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.
Eric Winquist, MD 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 [F-18]-FCH, PET scan and MRI scan in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 7 May 2019. 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 was stopped early (reason given: Low accrual). Results are not available in the source record.
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?
Number of lesions detected with 18F-FCH PET/MRI compared to conventional imaging (time frame: 3 years). 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 7 May 2019.