Clinical trial NCT04180592: Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: MRI
Prostate Biopsy
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over designed trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer]
timeFrame: Day 0
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
timeFrame: 0 Day and at 30 day
measure: Tolerability of CT fusion biopsy
timeFrame: Day 0
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
References: