A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches

Study Overview
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Brief Summary
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This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score >=7 or cancer core length >=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.

Detailed Description
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The feasibility of outpatient TPM has been well demonstrated.(Bianco & Martínez-Salamanca, 2016; Merrick et al., 2016; Smith et al., 2014) New technology now allows for fusion of MRI images with TPM devices, allowing for targeting of cancerous-appearing lesions on MRI. Such technology that fuses MRI-imaging with TRUS biopsy has become routine in U.S. clinical practice, with improved cancer detection rates as compared with standard TRUS.(Ahmed et al., 2017; Robertson, Emberton, & Moore, 2013) This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Men will be randomized to receiving either TPM or TRUS targeted biopsy. All men will receive a urine culture within 2 weeks of biopsy and will be started on antibiotic prophylaxis prior to biopsy in accordance with AUA antimicrobial prophylaxis guidelines. Men with a positive urine culture will be treated with culture-specific antibiotics and must have a documented negative urine culture prior to biopsy.

Official Title
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A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches: Transrectal Ultrasound-guided Biopsy Compared With a Transperineal Approach

Conditions
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Prostate Cancer, Elevated PSA

Intervention / Treatment
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* Procedure: prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men 18 years or older with suspicion for prostate cancer based upon an elevated PSA, abnormal digital rectal examination, abnormal MRI Men on active surveillance with indication for biopsy Exclusion Criteria: Men with active urinary tract infection, metastatic prostate cancer, history of colorectal surgery limiting insertion of transrectal probe, evidence of acute or chronic prostatitis, or concern for perineal cellulitis or fistula Men unfit to undergo prostate biopsy under local anesthesia Men with prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation Men with contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Men will be randomized to receiving either TPM or TRUS targeted biopsy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transrectal Ultrasound Guided Biopsy (TRUS)<br>Patients will receive a transrectal guided prostate biopsy | Procedure: prostate biopsy<br>* Men will be randomized to receiving either TPM or TRUS targeted biopsy<br>|
| Active Comparator: Transperineal Prostate Biopsy<br>Patients will receive a transperineal prostate biopsy | Procedure: prostate biopsy<br>* Men will be randomized to receiving either TPM or TRUS targeted biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gleason Grade | Detection of clinically significant disease Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3 and a secondary score of 4 have a fairly good outlook, whereas cancers with a primary Gleason Score of 4 and a secondary score of 3, are more likely to grow and spread. Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade. | 7 days post-biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported Pain, as Measured on a 0-10 Likert Scale | Pain will be scored on a 0-10 Likert scale. 0 indicates no pain and high scores indicate greater pain. | At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy | 
| Patient-reported Symptoms, as Measured by International Prostate Symptom Scores (IPSS) Questionnaire | IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms. | baseline, 7 days post-biopsy, 30 days post-biopsy | 
| Patient-reported Erectile Function, as Measured by International Index of Erectile Function (IIEF-5) Questionnaire | IIEF-5 scores range from 1 to 25, with 1-7 indicating severe erectile dysfunction, 8-11 indicating moderate erectile dysfunction, 12-16 indicating mild-moderate erectile dysfunction, 17-21 indicating mild erectile dysfunction, and 22-25 indicating no erectile dysfunction. | baseline, 7 days post-biopsy, 30 days post-biopsy | 
| Patient-reported Quality of Life, as Measured by EPIC-CP Questionnaire | EPIC-CP comprises of 10 questions about the patient within the last four weeks. Questions 1,7,8,9 are each graded on a scale from 0-4 for a total of 12 points. Higher scores indicate worse quality of life with regards to urinary and sexual function. Questions 2-4 grade Urinary Incontinence Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse urinary incontinence symptoms. Questions 5a-c grade Urinary Irritation/Obstructive Symptoms on a scale from 0-4 (max 12 poitns). Higher scores indicate worse urinary irritation/obstructive symptoms. Questions 6a-c grade Bowel Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse bowel symptoms. Questions 10a-c grade Vitality/Hormonal Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse vitality/hormonal symptoms. All scores are summed (max 60 points) to calculate the Overall Prostate Cancer QOL score. Higher score indicates worse patient-reported QOL. | baseline, 7 days post-biopsy, 30 days post-biopsy | 
| Adverse Events | Adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, hematochezia, and/or infection. | initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy |