Prostatic Neoplasms
Conditions
Keywords
prostate cancer diagnosis, magnetic resonance imaging, prostate biopsy
Brief summary
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.
Interventions
DEVICEmagnetic resonance imaging, Siemens
Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device
Sponsors
Oulu University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio \<=0.15, or total PSA 10-20 ng/ml) * PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies * No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)
Exclusion criteria
* Previous prostate biopsies * Previous prostate surgery * Contraindication for MRI (such as pacemaker or inner ear implant) * Claustrophobia * Estimated glomerular filtration rate (eGFR) \<40 ml/min * Suspected clinical T3-T4 prostate cancer based on digital rectal examination * Contraindication for transrectal ultrasound-guided prostate biopsies * body mass index \>30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Prostate Cancer Diagnoses in MRI and no MRI Groups | at the end of the study (up to 1 year) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Positive Biopsies in MRI and no MRI Groups | at the end of the study (up to 1 year) | 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. |
| Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups | at the end of the study (up to 1 year) | 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. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI Done Subjects with MRI prior prostate biopsies
magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device | 53 |
| no MRI No MRI before prostate biopsies | 60 |
| Total | 113 |
Baseline characteristics
| Characteristic | no MRI | Total | MRI Done |
|---|---|---|---|
| Age, Continuous | 62 years | 62 years | 63 years |
| Region of Enrollment Finland | 60 participants | 113 participants | 53 participants |
| Serum prostate-specific antigen level | 6.2 ng/ml | 6.1 ng/ml | 6.1 ng/ml |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 60 Participants | 113 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 1 / 60 |
| serious Total, serious adverse events | 0 / 53 | 0 / 60 |
Outcome results
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.
Time frame: at the end of the study (up to 1 year)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Done | Number of Prostate Cancer Diagnoses in MRI and no MRI Groups | 34 participants |
| no MRI | Number of Prostate Cancer Diagnoses in MRI and no MRI Groups | 34 participants |
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.
Time frame: at the end of the study (up to 1 year)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MRI Done | Number of Positive Biopsies in MRI and no MRI Groups | 3.0 number of cancer-positive biopsy cores |
| no MRI | Number of Positive Biopsies in MRI and no MRI Groups | 3.0 number of cancer-positive biopsy cores |
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.
Time frame: at the end of the study (up to 1 year)