Clinically Significant Prostate Cancer, Fusion Biopsy, Magnetic Resonance Imaging, Prostate Cancer, Target Lesion, Transperineal
Conditions
Keywords
prostate cancer, magnetic resonance imaging, transperineal biopsy, target lesion, fusion biopsy
Brief summary
Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.
Detailed description
In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy. Patients who fulfill all eligibility criteria and have provided written consent will be randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B). Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list. The primary end point will be the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm A mpMRI+ and arm B.
Interventions
DEVICEMRI/ultrasound transperineal prostate biopsy
3-6 targeted biopsy cores from each prostate region of interest
12 systematic biopsy cores
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list.
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males aged 18-75 years old 2. PSA \>1 ng/ml but \<15 ng/ml 3. Negative DRE 4. Signed informed consent
Exclusion criteria
1. Previous prostate biopsy or prostate surgery 2. Previous prostate mpMRI 3. Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices 4. Patients in the Texas Department of Criminal Justice (prisoners) 5. Patients with acute urinary symptoms including urinary retention and urinary tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Prostate Cancer | Within 2-4 wks after biopsy | Number of subjects with positive clinically significant prostate cancer results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B | Within 2-4 wks from biopsy | Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results. |
| Comparison of UTI Incidence in Arm A mpMRI+ and Arm B | From the time of biopsy through 4 weeks post-biopsy | Number of confirmed UTIs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI/Ultrasound Transperineal Prostate Biopsy In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS\<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.
MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest | 9 |
| Transrectal Ultrasound-guided Prostate Biopsy TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.
transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores | 11 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | MRI/Ultrasound Transperineal Prostate Biopsy | Total | Transrectal Ultrasound-guided Prostate Biopsy |
|---|---|---|---|
| Age, Continuous | 64 years | 62 years | 60 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 20 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 18 Participants | 10 Participants |
| Region of Enrollment United States | 9 participants | 20 participants | 11 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 20 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
Primary
Number of Participants With Clinically Significant Prostate Cancer
Number of subjects with positive clinically significant prostate cancer results
Time frame: Within 2-4 wks after biopsy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI/Ultrasound Transperineal Prostate Biopsy | Number of Participants With Clinically Significant Prostate Cancer | 6 Participants |
| Transrectal Ultrasound-guided Prostate Biopsy | Number of Participants With Clinically Significant Prostate Cancer | 6 Participants |
Secondary
Comparison of UTI Incidence in Arm A mpMRI+ and Arm B
Number of confirmed UTIs
Time frame: From the time of biopsy through 4 weeks post-biopsy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI/Ultrasound Transperineal Prostate Biopsy | Comparison of UTI Incidence in Arm A mpMRI+ and Arm B | 0 Participants |
| Transrectal Ultrasound-guided Prostate Biopsy | Comparison of UTI Incidence in Arm A mpMRI+ and Arm B | 0 Participants |
Secondary
Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B
Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.
Time frame: Within 2-4 wks from biopsy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI/Ultrasound Transperineal Prostate Biopsy | Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B | 8 Participants |
| Transrectal Ultrasound-guided Prostate Biopsy | Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B | 7 Participants |