Prostate CancerNCT03122470
Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer
A study testing MRI guided biopsy and TRUS biopsy in people with Prostate Cancer, run by Case Comprehensive Cancer Center.
Trial summary
MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI guided biopsy and TRUS biopsy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 20 Jun 2023
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer
- 1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)
Who cannot join
- Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
- The presence of an implanted pacemaker or implanted defibrillator device.
- Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
- Implanted medical device not described above that is not MRI-compatible;
- Known history of severe claustrophobia;
- For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) < 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed;
- Minors will be excluded.
- Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.
About this study
Official title: Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.
Read the detailed description
The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are:
- To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
- To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
- To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
- To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.
Secondary Objectives:
- To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer.
- To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
- To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.
- Conditions
- Prostate Cancer
- Being tested
- MRI guided biopsy, TRUS biopsy
- Keywords
- TRUS biopsy, Pelvic 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.
MRI guided biopsyDevice
Also called Prostate MRI, Pelvic MRI
The MRI guided biopsy will preferentially be performed using a 3 tesla (3T) Siemens Verio, or 3T Siemens Skyra machine. The multiparametric MRI exam will consist of T1-, T2- and diffusion weighted imaging with or without post-contrast perfusion studies. magnetic resonance fingerprinting (MRF) will be performed before contrast injection. The MRI will be interpreted by two specified radiologists from the research team.
TRUS biopsyProcedure or surgery
Also called Prostate Biopsy
The TRUS biopsy will be performed per current standard of care. Biopsy cores will be sent to pathology in separately labeled specimen cups. The final pathological results will be compared with pre-biopsy MRI findings.
| Study group | Role | What they receive |
|---|---|---|
| MRI guided biopsy + TRUS biopsy | Experimental | Patients will undergo an MRI guided biopsy and standard trans-rectal ultrasonography-guided (TRUS) biopsy. Results will be compared to see which can more accurately diagnose and manage prostate cancer Receives: Device: MRI guided biopsy; Procedure: TRUS biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with the most likely diagnosis based on the five-point scale - PIRADS
Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
Measured: Up to two weeks after MRI
Number of patients with true diagnosis based on biopsy pathology
- Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
Measured: Up to two weeks after MRI
Secondary outcomes (2)
biopsy and MRI based diagnosis match in at least 8/10 patients
The score based on the true diagnosis and most likely diagnosis as agreed on by classifiers is the same in at least 80% of patients
Measured: Up to two weeks after MRI
Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy
The diagnostic performance of MRI guided biopsy techniques will be compared with standard TRUS biopsy using a single sample of patients undergoing both biopsy techniques. It has been reported that MRI consistently detects a larger number of clinically significant prostate cancers (sensitivity - 0.91 for MRI-guided biopsy vs 0.76 for TRUS biopsy), while avoiding the detection of cancers that are clinically insignificant, as compared to TRUS biopsy.
Measured: Up to two weeks after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Aug 2017
- Primary completion20 May 2019
- Study completion20 Jun 2023 (estimated)
Why it stopped: PI departure - study not conducted.
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 Case Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Ponsky, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122470
- Sponsor's protocol ID
- CASE10815
- Status last verified
- Mar 2023
- First submitted
- 17 Apr 2017
- Last updated
- 16 Mar 2023
- Results posted
- No
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03122470
- Acronym / sponsor ID
- CASE10815
- Conditions
- Prostate Cancer
- Keywords
- TRUS biopsy, Pelvic MRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI departure - study not conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 20 Apr 2017 (actual)
- 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.
MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.
Detailed description
The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are:
- To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
- To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
- To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
- To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.
Secondary Objectives:
- To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer.
- To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
- To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI guided biopsy + TRUS biopsy | Experimental | Device: MRI guided biopsy, Procedure: TRUS biopsyPatients will undergo an MRI guided biopsy and standard trans-rectal ultrasonography-guided (TRUS) biopsy. Results will be compared to see which can more accurately diagnose and manage prostate cancer |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer
- 1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)
Key exclusion criteria (8 listed)
- Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
- The presence of an implanted pacemaker or implanted defibrillator device.
- Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
- Implanted medical device not described above that is not MRI-compatible;
- Known history of severe claustrophobia;
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 |
|---|---|---|
| MRI guided biopsyAlso: Prostate MRI, Pelvic MRIThe MRI guided biopsy will preferentially be performed using a 3 tesla (3T) Siemens Verio, or 3T Siemens Skyra machine. The multiparametric MRI exam will consist of T1-, T2- and diffusion weighted imaging with or without post-contrast perfusion studies. magnetic resonance fingerprinting (MRF) will be performed before contrast injection. The MRI will be interpreted by two specified radiologists from the research team. | Device | MRI guided biopsy + TRUS biopsy |
| TRUS biopsyAlso: Prostate BiopsyThe TRUS biopsy will be performed per current standard of care. Biopsy cores will be sent to pathology in separately labeled specimen cups. The final pathological results will be compared with pre-biopsy MRI findings. | Procedure or surgery | MRI guided biopsy + TRUS biopsy |
Primary outcome
Number of patients with the most likely diagnosis based on the five-point scale - PIRADS
Time frame: Up to two weeks after MRI
Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
Number of patients with true diagnosis based on biopsy pathology
Time frame: Up to two weeks after MRI
1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
2 secondary outcomes
biopsy and MRI based diagnosis match in at least 8/10 patients
Time frame: Up to two weeks after MRI
Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy
Time frame: Up to two weeks after MRI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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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.
Lee Ponsky, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing MRI guided biopsy and TRUS biopsy in people with Prostate Cancer, run by Case Comprehensive Cancer Center.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 patients with the most likely diagnosis based on the five-point scale - PIRADS (time frame: Up to two weeks after MRI). 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 16 Mar 2023.