Clinical trial NCT03632655: A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches
Official title: A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches: Transrectal Ultrasound-guided Biopsy Compared With a Transperineal Approach
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Elevated PSA
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Men will be randomized to receiving either TPM or TRUS targeted biopsy.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Gleason Grade
timeFrame: 7 days post-biopsy
Secondary outcomes:
measure: Patient-reported Pain, as Measured on a 0-10 Likert Scale
timeFrame: At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy
measure: Patient-reported Symptoms, as Measured by International Prostate Symptom Scores (IPSS) Questionnaire
timeFrame: baseline, 7 days post-biopsy, 30 days post-biopsy
measure: Patient-reported Erectile Function, as Measured by International Index of Erectile Function (IIEF-5) Questionnaire
timeFrame: baseline, 7 days post-biopsy, 30 days post-biopsy
measure: Patient-reported Quality of Life, as Measured by EPIC-CP Questionnaire
timeFrame: baseline, 7 days post-biopsy, 30 days post-biopsy
measure: Adverse Events
timeFrame: initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jim Hu, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: