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出境医 / 临床实验 / Micro-Ultrasound/Magnetic Resonance Imaging 001
Micro-Ultrasound/Magnetic Resonance Imaging 001
Study Description
Brief Summary:
Micro-ultrasound is a novel real-time imaging modality which maintains the clinical workflow of conventional ultrasound-guided prostate biopsy, while potentially maintaining a similar ability to detect clinically significant prostate cancer (csPCa) to MRI. This prospective trial aims to compare micro-ultrasound to mpMRI in detection of csPCa in the biopsy naïve.
| Condition or disease | Intervention/treatment |
|---|---|
| Diagnoses Disease | Diagnostic Test: Micro-Ultrasound guided biopsy |
Detailed Description:
Evidence from a large randomized clinical trial (clinical trials.gov ID NCT02079025), suggests that micro-ultrasound system is more sensitive than conventional transrectal-ultrasound (TRUS) to detect prostate cancer (PCa). the PRI-MUS (prostate risk identification using micro-ultrasound) scoring system was developed and validated to assess the risk of prostate cancer for targeted biopsy with the micro-ultrasound platform, similar to the PIRADS scoring system for suspicious areas on mpMRI. This project will compare micro-ultrasound imaging modality to the current gold-standard imaging for prostate cancer, mpMRI. By applying both modalities to the same patients, the investigators will provide a direct comparison of their screening abilities in terms of sensitivity, specificity, negative predictive value and positive predictive value. It will build evidence to demonstrate that micro-ultrasound may replace MRI/Fusion biopsy in these patients.This project aims to demonstrate that the micro-ultrasound 1) provides more sensitive initial biopsy, reducing the need for repeated procedures, thus lowering the rate of severe sepsis and the number of cancers found after local or regional progression, and 2) reduces the need for mpMRI following initial biopsy.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Comparison of Micro-ultrasound Targeted Biopsy to mpMRI of Prostate for Detection of Clinically Significant Prostate Cancer |
| Actual Study Start Date : | May 24, 2019 |
| Actual Primary Completion Date : | September 14, 2020 |
| Actual Study Completion Date : | February 1, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Potential Prostate Cancer
Biopsy naïve patients with rising Prostate Specific Antigen (PSA) results referred by their Urologist for a standard of care (SOC) biopsy.
|
Diagnostic Test: Micro-Ultrasound guided biopsy
High-resolution imaging device
|
Outcome Measures
Primary Outcome Measures :
- The proportion of csPCa detected for each modality. [ Time Frame: 1.5 years ]Micro-ultrasound targeted biopsy will provide a non-inferior sensitivity to detect clinically significant prostate cancer compared to multiparametric MRI.
Secondary Outcome Measures :
- The proportion of zones of PCa correctly predicted by each modality in the whole-mount pathology specimen for the subset of men selecting radical prostatectomy for treatment. [ Time Frame: 1.5 years ]Micro-ultrasound will correctly predict extent of disease in the subset of biopsy subjects who proceed to radical prostatectomy.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Based on the individual's biology, must have suspicion for prostate cancer based on Prostate Specific Antigen (PSA) results. |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who are referred to confirm negative or positive for diagnosis of prostate cancer based on SOC biopsy, with superior resolution imaging devices. Referral may be indicated in the setting of increased PSA, abnormal DRE and/or abnormality of other serum or urinary tests specific for prostate cancer, for example PHI (Prostate Health Index) and PCA3. The current golden standard imaging for prostate cancer is mpMRI.
Criteria
Inclusion Criteria:
- Men with indication for a prostate biopsy will be offered inclusion in the study. Indications for biopsy include clinical suspicion of prostate cancer due to elevated PSA or abnormal digital rectal exam (DRE)
Exclusion Criteria:
- Patients with history of prostate cancer
- Patients with prior prostate biopsies
- Patients who are unwilling or unable to give informed consent
- Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
Contacts and Locations
Locations
| Canada, Ontario | |
| Princess Margaret Cancer Centre | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
University Health Network, Toronto
Investigators
| Principal Investigator: | Sangeet Ghai, MD | University Health Network, Toronto |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | April 3, 2019 | ||||||
| First Posted Date | May 6, 2019 | ||||||
| Last Update Posted Date | April 1, 2021 | ||||||
| Actual Study Start Date | May 24, 2019 | ||||||
| Actual Primary Completion Date | September 14, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
The proportion of csPCa detected for each modality. [ Time Frame: 1.5 years ] Micro-ultrasound targeted biopsy will provide a non-inferior sensitivity to detect clinically significant prostate cancer compared to multiparametric MRI.
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
The proportion of zones of PCa correctly predicted by each modality in the whole-mount pathology specimen for the subset of men selecting radical prostatectomy for treatment. [ Time Frame: 1.5 years ] Micro-ultrasound will correctly predict extent of disease in the subset of biopsy subjects who proceed to radical prostatectomy.
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Micro-Ultrasound/Magnetic Resonance Imaging 001 | ||||||
| Official Title | Comparison of Micro-ultrasound Targeted Biopsy to mpMRI of Prostate for Detection of Clinically Significant Prostate Cancer | ||||||
| Brief Summary | Micro-ultrasound is a novel real-time imaging modality which maintains the clinical workflow of conventional ultrasound-guided prostate biopsy, while potentially maintaining a similar ability to detect clinically significant prostate cancer (csPCa) to MRI. This prospective trial aims to compare micro-ultrasound to mpMRI in detection of csPCa in the biopsy naïve. | ||||||
| Detailed Description | Evidence from a large randomized clinical trial (clinical trials.gov ID NCT02079025), suggests that micro-ultrasound system is more sensitive than conventional transrectal-ultrasound (TRUS) to detect prostate cancer (PCa). the PRI-MUS (prostate risk identification using micro-ultrasound) scoring system was developed and validated to assess the risk of prostate cancer for targeted biopsy with the micro-ultrasound platform, similar to the PIRADS scoring system for suspicious areas on mpMRI. This project will compare micro-ultrasound imaging modality to the current gold-standard imaging for prostate cancer, mpMRI. By applying both modalities to the same patients, the investigators will provide a direct comparison of their screening abilities in terms of sensitivity, specificity, negative predictive value and positive predictive value. It will build evidence to demonstrate that micro-ultrasound may replace MRI/Fusion biopsy in these patients.This project aims to demonstrate that the micro-ultrasound 1) provides more sensitive initial biopsy, reducing the need for repeated procedures, thus lowering the rate of severe sepsis and the number of cancers found after local or regional progression, and 2) reduces the need for mpMRI following initial biopsy. | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Patients who are referred to confirm negative or positive for diagnosis of prostate cancer based on SOC biopsy, with superior resolution imaging devices. Referral may be indicated in the setting of increased PSA, abnormal DRE and/or abnormality of other serum or urinary tests specific for prostate cancer, for example PHI (Prostate Health Index) and PCA3. The current golden standard imaging for prostate cancer is mpMRI. | ||||||
| Condition | Diagnoses Disease | ||||||
| Intervention | Diagnostic Test: Micro-Ultrasound guided biopsy
High-resolution imaging device
|
||||||
| Study Groups/Cohorts | Potential Prostate Cancer
Biopsy naïve patients with rising Prostate Specific Antigen (PSA) results referred by their Urologist for a standard of care (SOC) biopsy.
Intervention: Diagnostic Test: Micro-Ultrasound guided biopsy
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
100 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Actual Study Completion Date | February 1, 2021 | ||||||
| Actual Primary Completion Date | September 14, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Canada | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03938376 | ||||||
| Other Study ID Numbers | 19-5042.0 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Health Network, Toronto | ||||||
| Study Sponsor | University Health Network, Toronto | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | University Health Network, Toronto | ||||||
| Verification Date | March 2021 | ||||||
