Prostate Cancer
Conditions
Brief summary
The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.
Detailed description
Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.
Interventions
DEVICEArtemis™ software system
Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score \>3/5)
Exclusion criteria
* Prior pelvic radiotherapy * Evidence of urinary tract infection or significant urinary retention * Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI * No evidence of suspicious lesions on mpMRI * Irreversible coagulopathy * Contraindication to sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core Cancer Length | 2 Months | Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of High-Grade Prostate Cancer Using Gleason Score | 2 Months | High-grade prostate cancer is defined as a Gleason score \> 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor. Data is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI Targeted Biopsy Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible (could not reach perinium) | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Study Closure (interim analysis showed no significant results) | 4 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | MRI Targeted Biopsy |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 2 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Core Cancer Length
Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)
Time frame: 2 Months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MRI Targeted Biopsy | Core Cancer Length | TP | 5 mm |
| MRI Targeted Biopsy | Core Cancer Length | TR | 6 mm |
| MRI Targeted Biopsy | Core Cancer Length | TP+TR | 5 mm |
Secondary
Percentage of High-Grade Prostate Cancer Using Gleason Score
High-grade prostate cancer is defined as a Gleason score \> 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor. Data is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)
Time frame: 2 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MRI Targeted Biopsy | Percentage of High-Grade Prostate Cancer Using Gleason Score | TP | 34 percentage of prostate cancer grades |
| MRI Targeted Biopsy | Percentage of High-Grade Prostate Cancer Using Gleason Score | TR | 40 percentage of prostate cancer grades |
| MRI Targeted Biopsy | Percentage of High-Grade Prostate Cancer Using Gleason Score | TP+TR | 49 percentage of prostate cancer grades |