A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/17/2018 |
| Start Date: | December 23, 2017 |
| End Date: | January 10, 2020 |
| Contact: | Miko Yu |
| Email: | mey2006@med.cornell.edu |
| Phone: | 212-746-1496 |
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches: Transrectal Ultrasound-guided Biopsy Compared With a Transperineal Approach
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10065
Principal Investigator: Jim C Hu, M.D., M.P.H.
Phone: 212-746-1496
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