Prostate CancerNCT03292874
High Resolution MRI Study for Prostate Cancer
A study testing high resolution MRI (hrMRI) in people with Prostate Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- high resolution MRI (hrMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 14 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Patients diagnosed with clinically localized prostate cancer
- Low or Low-intermediate Risk Prostate cancer1 defined as:
- Pre-operative prostate specific antigen (PSA) ≤ 20.0 ng/ml
- Clinical stage cT1 or cT2
- Gleason score 3+3 or 3+4
Show all 9Show fewer
- Patients choosing AS or already on AS as primary management strategy
- No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
- No contraindications for gadolinium enhanced MRI
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Evaluation of a Novel High-Resolution Diffusion-Weighted MRI Sequence
This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. This study evaluates the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes will correlate with prostate cancer progression as determined on prostate biopsy.
Read the detailed description
2.0 BACKGROUND AND RATIONALE
Multiparametric MRI Multiparametric MRI combining T2-weighted, diffusion-weighted, and dynamic contrast enhanced (DCE) images is commonly employed for detection and localization of prostate lesions. Diffusion-weighted imaging (DWI) is sensitive to the diffusion of water molecules interacting with surrounding macromolecules. DWI, which provides a quantitative biological parameter called apparent diffusion coefficient (ADC) value, is a robust MRI parameter for differentiating benign and malignant prostate tissue. In fact, the latest version of the Prostate Imaging-Reporting and Data System (PI-RADS) scoring system relies almost exclusively on DWI to identify tumors in the peripheral zone, which is where the vast majority of prostate cancers form. Findings on T2 images are not used to identify cancer, and DCE images are only used to differentiate between some PI-RADS 3 and 4 lesions. In a pilot study of prostate cancer AS, DW-MRI was useful for detecting progression of Gleason score based on changes in ADC value. Tumor size is another important clinical criterion for defining low risk prostate cancer, and tumor size based on DWI has been shown to crudely predict low risk prostate cancer. However, conventional DWI using single-shot echo-planar imaging is unable to detect small tumors, low grade tumors, or small changes in tumor size on serial imaging. Approximately 20% of small, low grade tumors found in men on AS are detected on modern prostate MRI.
High Resolution MRI Investigators introduce a new three-dimensional (3D) high-resolution diffusion-weighted imaging sequence (HR-DWI), which improves image quality while conferring at least a 5-fold improvement in resolution when compared to standard two-dimensional (2D) DWI (S-DWI). This novel 3D DWI technique has been developed by our team and can be applied on existing 1.5T or 3T MRI systems. S-DWI suffers from two important limitations. a) It uses single-shot echo-planar imaging (EPI) for data acquisition, which produces magnetic susceptibility induced streaking artifacts and geometric distortions so that round objects may appear oval. b) The relatively low signal-to-noise ratio and 2D image acquisition with S-DWI limit spatial resolution, which is defined by the minimum distance between two objects required to resolve them uniquely. Our HR-DWI overcomes these limitations by using magnetization prepared, multi-shot, turbo-spin-echo acquisition, which improves signal-to-noise ratio (SNR), spatial resolution, and image quality, and eliminates geometric distortions and streaking artifacts associated with EPI.
Preliminary studies
In preliminary studies assessing the performance of our HR-DWI in a prospective pilot trial of prostate cancer AS patients, the technique could detect tumors not seen on S-DWI and measure ADC, which correlates with grade. This is important because the long-term natural history of small prostate cancers invisible to S-DWI has never been prospectively defined, in part due to lack of adequate imaging technology. In the era of molecular diagnostics and next-generation sequencing, an important step in understanding the biology of these lesions is to develop technologies to image and characterize these lesions. Importance of HR-DWI includes:
- Better imaging will allow these lesions to be monitored serially and targeted for biopsy, providing tissue for both histologic and molecular characterization.
- Higher resolution imaging will better delineate tumor boundaries, which can improve tumor staging and identify margins during partial-gland ablation by cryotherapy or high intensity focused ultrasound (HIFU), which was approved in 2015 by the U.S. FDA.
- Improved imaging resolution will allow for more accurate measurement of tumor size and ADC, and detection of small changes in size or grade over time. Standard prostate DWI has poor resolution; therefore, tumor growth kinetics have never been accepted as clinical criteria for cancer progression while on AS. If tumor growth kinetics or changes in grade determined by ADC prove prognostic, AS can rely less on serial transrectal biopsies, which can lead to serious complications.
- Conditions
- Prostate Cancer
- Being tested
- high resolution MRI (hrMRI)
- Keywords
- prostate cancer, 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.
high resolution MRI (hrMRI)Diagnostic test
high resolution MRI (hrMRI) and standard MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Paired imaging | Other | Single arm, paired imaging of high resolution MRI (hrMRI) and stand MRI (sMRI) Receives: Diagnostic Test: high resolution MRI (hrMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology
The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.
Measured: 6-12 months after enrollment
Area Under the Receiver Operator Curve of High Resolution Versus Standard MRI in Identifying Adverse Histology
The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.
Measured: 6-12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start13 Sep 2017
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, paired imaging
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung L. Kim, MD, Cedars-Sinai Medical Center
- Investigators
- Hyung L Kim, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292874
- Sponsor's protocol ID
- Pro00049177
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2017
- Last updated
- 3 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel High-Resolution Diffusion-Weighted MRI Sequence
- ClinicalTrials.gov ID
- NCT03292874
- Acronym / sponsor ID
- Pro00049177
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. This study evaluates the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes will correlate with prostate cancer progression as determined on prostate biopsy.
Detailed description
2.0 BACKGROUND AND RATIONALE
Multiparametric MRI Multiparametric MRI combining T2-weighted, diffusion-weighted, and dynamic contrast enhanced (DCE) images is commonly employed for detection and localization of prostate lesions. Diffusion-weighted imaging (DWI) is sensitive to the diffusion of water molecules interacting with surrounding macromolecules. DWI, which provides a quantitative biological parameter called apparent diffusion coefficient (ADC) value, is a robust MRI parameter for differentiating benign and malignant prostate tissue. In fact, the latest version of the Prostate Imaging-Reporting and Data System (PI-RADS) scoring system relies almost exclusively on DWI to identify tumors in the peripheral zone, which is where the vast majority of prostate cancers form. Findings on T2 images are not used to identify cancer, and DCE images are only used to differentiate between some PI-RADS 3 and 4 lesions. In a pilot study of prostate cancer AS, DW-MRI was useful for detecting progression of Gleason score based on changes in ADC value. Tumor size is another important clinical criterion for defining low risk prostate cancer, and tumor size based on DWI has been shown to crudely predict low risk prostate cancer. However, conventional DWI using single-shot echo-planar imaging is unable to detect small tumors, low grade tumors, or small changes in tumor size on serial imaging. Approximately 20% of small, low grade tumors found in men on AS are detected on modern prostate MRI.
High Resolution MRI Investigators introduce a new three-dimensional (3D) high-resolution diffusion-weighted imaging sequence (HR-DWI), which improves image quality while conferring at least a 5-fold improvement in resolution when compared to standard two-dimensional (2D) DWI (S-DWI). This novel 3D DWI technique has been developed by our team and can be applied on existing 1.5T or 3T MRI systems. S-DWI suffers from two important limitations. a) It uses single-shot echo-planar imaging (EPI) for data acquisition, which produces magnetic susceptibility induced streaking artifacts and geometric distortions so that round objects may appear oval. b) The relatively low signal-to-noise ratio and 2D image acquisition with S-DWI limit spatial resolution, which is defined by the minimum distance between two objects required to resolve them uniquely. Our HR-DWI overcomes these limitations by using magnetization prepared, multi-shot, turbo-spin-echo acquisition, which improves signal-to-noise ratio (SNR), spatial resolution, and image quality, and eliminates geometric distortions and streaking artifacts associated with EPI.
Preliminary studies
In preliminary studies assessing the performance of our HR-DWI in a prospective pilot trial of prostate cancer AS patients, the technique could detect tumors not seen on S-DWI and measure ADC, which correlates with grade. This is important because the long-term natural history of small prostate cancers invisible to S-DWI has never been prospectively defined, in part due to lack of adequate imaging technology. In the era of molecular diagnostics and next-generation sequencing, an important step in understanding the biology of these lesions is to develop technologies to image and characterize these lesions. Importance of HR-DWI includes:
- Better imaging will allow these lesions to be monitored serially and targeted for biopsy, providing tissue for both histologic and molecular characterization.
- Higher resolution imaging will better delineate tumor boundaries, which can improve tumor staging and identify margins during partial-gland ablation by cryotherapy or high intensity focused ultrasound (HIFU), which was approved in 2015 by the U.S. FDA.
- Improved imaging resolution will allow for more accurate measurement of tumor size and ADC, and detection of small changes in size or grade over time. Standard prostate DWI has poor resolution; therefore, tumor growth kinetics have never been accepted as clinical criteria for cancer progression while on AS. If tumor growth kinetics or changes in grade determined by ADC prove prognostic, AS can rely less on serial transrectal biopsies, which can lead to serious complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, paired imaging
| Arm | Type | Receives |
|---|---|---|
| Paired imaging | Other | Diagnostic Test: high resolution MRI (hrMRI)Single arm, paired imaging of high resolution MRI (hrMRI) and stand MRI (sMRI) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age over 18 years
- Patients diagnosed with clinically localized prostate cancer
- Low or Low-intermediate Risk Prostate cancer1 defined as:
- Pre-operative prostate specific antigen (PSA) ≤ 20.0 ng/ml
- Clinical stage cT1 or cT2
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| high resolution MRI (hrMRI)high resolution MRI (hrMRI) and standard MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. | Diagnostic test | Paired imaging |
Primary outcome
Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology
Time frame: 6-12 months after enrollment
The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.
Area Under the Receiver Operator Curve of High Resolution Versus Standard MRI in Identifying Adverse Histology
Time frame: 6-12 months after enrollment
The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hyung L Kim, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high resolution MRI (hrMRI) in people with Prostate Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
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 1 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology (time frame: 6-12 months after enrollment). The study lists 2 primary outcomes in all. 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 3 Apr 2024.