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.
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.
This will be a prospective randomized controlled trial using a cross over design. Patients
will serve as their own controls and undergo both TRUSP biopsy (standard of care) and mpMRI
fused to cone beam CT guided biopsy of the prostate. The procedures and recovery will follow
the identical standardized care pathway that is currently used for TRUSP biopsies. A total of
20 patients will be recruited
Patients will be randomized to receive either TRUSP biopsy or cone beam CT guided biopsy
first, followed by the alternative procedure. Following the initial biopsy procedure the
patients will fill out a short pain score. They will then recover in the radiology suite for
a period of one hour. Following a one hour recovery period the patient will subsequently
undergo the alternative biopsy procedure. They will then fill out a second pain score with
two additional questions asking the patient to compare the two biopsy approaches with respect
to comfort and preference using a 7 point Likert scale. Specimens will be sent to pathology
separately to detect differences in diagnostic yield between the two biopsy approaches. In
order to minimize inter-operator variability in outcomes, Dr. Menard will perform all
biopsies regardless of approach.
An interim analysis after 10 patients will be performed. The study will be terminated early
if:
1. No TRUSP biopsy detects any form of prostate cancer
2. No cone beam CT guided biopsy detects any form of prostate cancer.
3. Average pain scores between biopsy approaches differ by more than 4 points on the
Universal Pain Assessment scale.
4. 3 or more patients suffer any of:
1. Immediate procedure related complications
2. 30 day return to the emergency room
3. 30 day hospital admission
Measures
Feasibility:
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.
Safety:
Immediate procedure related complications, 30 day return to the ER and 30 day hospital
admission rates will be recorded. Immediate procedure related complications will be
documented at the time of the procedure. The 30 day return to the ER and hospital admission
rates will be documented at the participant's followup appointment. Complication rates will
reflect the total combined complication rate. This can be compared against the known Ontario
province rates to ensure that the addition of cone beam CT guided biopsy does not provide for
additive morbidity.
Tolerability:
Patients will fill out the Universal Pain Assessment Tool after each procedure. After both
procedures are completed, patients will fill out two questions utilizing a 7 point Likert
scale on preference and comfort between the two biopsy approaches.
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