Prostate Cancer Clinical Trial
Official title:
Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate: The Safety and Feasibility of a Novel Method of Prostate Biopsy.
NCT number | NCT04180592 |
Other study ID # | 6018147 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 6, 2019 |
Est. completion date | August 2020 |
The purpose of this study is to investigate a novel method of prostate biopsy using a computerized guidance system to accurately target lesions within the prostate. This method of prostate biopsy involves using a computerized technology that permits a lesion detected on MRI to be projected by a computer into 3 dimensions on a patient's CT scan. A CT guided biopsy can then be performed where a needle is advanced into the patient, where the computer has projected the image of the tumor that cannot normally be seen on CT. This is a randomized, cross over designed trial to compare this new method of prostate biopsy to the currently employed standard transrectal ultrasound guided prostate (TRUSP) biopsy technique.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Participants will be eligible for enrollment if they have both of: 1. Lesion in the prostate on mpMRI that is highly likely to be clinically significant prostate cancer based on the PI-RADS version 2 score (PI-RADS score of 4 or 5). 2. A previous negative TRUSP biopsy or previous TRUSP biopsy showing atypical small acinar proliferation, high grade prostatic intraepithelial neoplasia or low volume Gleason 6 disease (low risk disease) all of which are incongruent with the high PI-RADS score of the mpMRI lesion. Exclusion Criteria: 1. Uncorrected coagulopathy. 2. Active, untreated urinary tract infection. 3. Inability to access the rectum in order to perform TRUSP biopsy. |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer] | Patients will be considered to have clinically significant prostate cancer based on their PI-RADS score 4 or 5. The ability of TRUSP biopsy and cone beam CT guided biopsy to detect any form of prostate cancer as well as clinically significant prostate cancer (defined as prostate cancer with a Gleason score =7) will serve as the primary outcome measures. | Day 0 | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | Immediate procedure related complications will be documented at the time of procedures. The 30 day return to the ER and hospital admission rates will be documented at the participant's following appointment. | 0 Day and at 30 day | |
Secondary | Tolerability of CT fusion biopsy | Patients will fill out the 0-10 point Universal Pain Assessment Tool after each procedure where 0 is no pain and 10 is the worst pain possible. After both procedures are completed, patients will also fill out two questions utilizing a 1-7 point Likert scale on preference and comfort between the two biopsy approaches where 1 represents rectum biopsy and 7 represents buttock muscle biopsy. | Day 0 |
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