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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
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The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI done | Experimental | Subjects with MRI prior prostate biopsies |
|
| no MRI | No Intervention | No MRI before prostate biopsies |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging, Siemens | Device | Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Prostate Cancer Diagnoses in MRI and no MRI Groups | The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group. | at the end of the study (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Positive Biopsies in MRI and no MRI Groups | The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markku Vaarala, MD PhD | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | 90029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26033153 | Derived | Tonttila PP, Lantto J, Paakko E, Piippo U, Kauppila S, Lammentausta E, Ohtonen P, Vaarala MH. Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial. Eur Urol. 2016 Mar;69(3):419-25. doi: 10.1016/j.eururo.2015.05.024. Epub 2015 May 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI Done | Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device |
| FG001 | no MRI | No MRI before prostate biopsies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Population with protocol violations excluded
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI Done | Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device |
| BG001 | no MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Prostate Cancer Diagnoses in MRI and no MRI Groups | The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group. | Posted | Number | participants | at the end of the study (up to 1 year) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI Done | Subjects with MRI prior prostate biopsies magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| collapse | Cardiac disorders | Non-systematic Assessment | Collapse after prostate biopsy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief urologist Markku Vaarala | Oulu University Hospital and Univeristy of Oulu | +3588315 | 2840 | markku.vaarala@oulu.fi |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| at the end of the study (up to 1 year) |
| Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups | Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores. | at the end of the study (up to 1 year) |
No MRI before prostate biopsies
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum prostate-specific antigen level | Median | Inter-Quartile Range | ng/ml |
|
No MRI before prostate biopsies
|
|
| Secondary | Number of Positive Biopsies in MRI and no MRI Groups | The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively. | Posted | Median | Inter-Quartile Range | number of cancer-positive biopsy cores | at the end of the study (up to 1 year) |
|
|
|
| Secondary | Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups | Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores. | Not Posted | at the end of the study (up to 1 year) | Participants |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | no MRI | No MRI before prostate biopsies | 0 | 60 | 1 | 60 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |