Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT04180592
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT04180592
Study Brief:
Protocol Section:
NCT04180592