- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632655
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches: Transrectal Ultrasound-guided Biopsy Compared With a Transperineal Approach
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transrectal Ultrasound Guided Biopsy (TRUS)
Patients will receive a transrectal guided prostate biopsy
|
Men will be randomized to receiving either TPM or TRUS targeted biopsy
|
Active Comparator: Transperineal Prostate Biopsy
Patients will receive a transperineal prostate biopsy
|
Men will be randomized to receiving either TPM or TRUS targeted biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gleason Grade
Time Frame: 7 days post-biopsy
|
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.
|
7 days post-biopsy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-reported Pain, as Measured on a 0-10 Likert Scale
Time Frame: At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy
|
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
Time Frame: baseline, 7 days post-biopsy, 30 days post-biopsy
|
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
Time Frame: baseline, 7 days post-biopsy, 30 days post-biopsy
|
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
Time Frame: baseline, 7 days post-biopsy, 30 days post-biopsy
|
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
Time Frame: initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jim Hu, M.D., M.P.H., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1705018187
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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