Clinical trial NCT04843566
Conditions: Infection
Keywords: prostate cancer prostate biopsy biopsy infection fusion biopsy MRI-targeted biopsy transperineal transrectal
Sponsor: Weill Medical College of Cornell University
Start date: 2021-03-22; Completion date: 2024-04-19
Enrollment: 687 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.

This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy.

The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.

Detailed description:
Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is performed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

Arms: arm 1: Patients will receive a transrectal MRI-guided prostate biopsy. arm 2: Patients will receive a transperineal MRI-guided prostate biopsy.
Interventions: intervention 1: Transperineal MRI-guided prostate biopsy intervention 2: Transrectal MRI-guided prostate biopsy intervention 3: Antibiotic (prophylaxis)
Intervention descriptions: intervention 1: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking. intervention 2: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. intervention 3: For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).

No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.

Protocol documents:
Prot_SAP_001.pdf: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title: Randomized controlled trial assessing transperineal prostate biopsy to reduce infection 
complications 
NCT04843566 
Document date: 10/24/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


BRANY ID # 18-02-365 
Version/Date: v5.5, 24-OCT-2023 
TITLE:  Randomized controlled trial assessing transperineal prostate biopsy to reduce infection 
complications 
BRANY ID # 18-02-365 VERSION/DATE: v5.5, 24-OCT-2023 
Principal Investigator: 
Jim C. Hu, MD MPH (contact) 
525 E 68th Street, Starr 946 
New York, NY 10065 
Weill Cornell Medicine 
Telephone 646.962.9600 
Fax 646.962.0715 
jch9011@med.cornell.edu 
Edward M. Schaeffer, MD PhD 
NMH/Arkes Family Pavilion Suite 2300 
676 N Saint Clair 
Chicago, IL 60611 
Northwestern University 
Telephone 312.908.8145 e-
schaeffer@northwestern.edu 
Mohamad Allaf, MD 
600 North Wolfe Street, Park 223 
Baltimore, MD 21287 
Johns Hopkins University 
Telephone 410.502.7710 
Fax 410.502.7711 
mallaf@jhmi.edu 
Co-Investigators: 
Behfar Ehdaie, MD MPH 
323 E 68th Street 
New York, NY 10065 
Memorial Sloan Kettering Cancer Center 
Telephone 646.422.4406 
ehdaieb@mskcc.org 
Timothy McClure, MD 
525 E 68th Street, Starr 900 
New York, NY 10065 
Weill Cornell Medicine 
Telephone 646.962.9600 
tim9047@med.cornell.edu 
Anthony Schaeffer, MD 
675 N Saint Clair, Ste 20-150 
Chicago, IL 60611 
Northwestern University 
ajschaeffer@northwestern.edu 
Ashley Ross, MD, PhD 


675 N Saint Clair, Ste 20-150 
Chicago, IL 60611 
Northwestern University 
Telephone 312.695.8146 
ashley.ross@nm.org 
Jeffrey Montgomery, MD 
1500 E Medical Center Dr SPC 5913 
Ann Arbor, MI 48109 
University of Michigan 
Telephone 734.647.8903 
montrose@med.umich.edu 
Arvin George, MD 
1500 E Medical Center Dr, Floor 2 
Ann Arbor, MI 48109 
University of Michigan 
Telephone 734.936.7030 
arvigeor@med.umich.edu 
John Graham, MD 
38 6th Avenue, 2nd Floor 
Brooklyn, NY 11217 
NewYork-Presbyterian Brooklyn Methodist Hospital 
Telephone 718.230.7788 
jng9008@med.cornell.edu 
David Green, MD 
58-42 Main Street 
Flushing, NY 11355 
NewYork-Presbyterian Queens 
Telephone 718.303.3720 
dag9025@nyp.org 
Gerald Wang, MD 
56-45 Main Street 
Flushing, NY 11355 
NewYork-Presbyterian Queens 
Telephone 718.303.3720 
gew9003@nyp.org 
Serge Ginzburg, MD 
1200 Tabor Rd, 3rd Floor 
Philadelphia, PA 19141 
Einstein Urology 
Telephone 215.356.4658 
ginzburs@einstein.edu 
Keith Kowalczyk, MD 
3800 Reservoir Road Northwest, 4th Floor 
Washington, DC 20007 


Georgetown University 
Telephone 202.295.0580 
keith.kowalczyk@medstar.net 
Andres Correa 
333 Cottman Avenue 
Philadelphia, PA 19111 
Fox Chase Cancer Center 
Telephone 215.728.6900 
andres.correa@fccc.edu 
Benjamin Ristau, MD 
263 Farmington Avenue 
Farmington, CT 06030 
University of Connecticut 
Telephone 860.679.4100 
beristau@uchc.edu 
Jonathan Shoag, MD 
11100 Euclid Avenue 
Cleveland, OH 44106 
Case Western University 
Telephone 216.844.3009 
jxs218@case.edu 
Statistician:  
Andrew Vickers, PhD 
485 Lexington Ave 
New York, NY 10017 
Memorial Sloan Kettering Cancer Center 
Telephone 646.888.8233 
vickersa@MSKCC.org Confidentiality 
Statement 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or 
institutional review boards. The contents of this document shall not be disclosed to others 
without written authorization from the Principal Investigator. 
 


  
Protocol Summary 
Full Title: 
Randomized controlled trial assessing transperineal prostate 
biopsy to reduce infection complications 
Clinical Phase: 
II 
Principal Investigator: 
Jim C. Hu, M.D., M.P.H. 
Sample Size: 
N= 1,702 
Study Population: 
Men who are aged at least 18 years with: history of Grade Group 
1 or 2 prostate cancer, first diagnosed prior to date of planned 
biopsy (active surveillance cohort); clinical concern for the 
presence of prostate cancer as determined by the treating 
urologist and prior negative prostate biopsy performed ≤36 
months prior to date of planned biopsy (prior negative cohort); 
Men without previous prostate biopsy (first time prostate biopsy) 
Accrual Period: 
Approximately 31 months  
Study Design: 
Prospective, randomized trial with 1:1 ratio to either the 
transperineal or transrectal biopsy group. Participants will be 
assessed for adverse events, pain and discomfort immediately and 
7 days post-biopsy.  
Intervention Description: 
Transrectal prostate biopsy (TR-Bx) under local anesthesia is 
currently the most commonly used approach to evaluate for the 
presence of prostate cancer. A limitation of TR-Bx is the need for 
biopsy needles to pass through the rectal mucosa on their 
trajectory to the prostate, placing men at high risk of an infectious 
complication. An alternative method for performing prostate biopsy 
is via a percutaneous transperineal approach. One limitation of 
transperineal prostate biopsy (TP-Bx) has been the historic need 
for it to be performed under general or spinal anesthesia in order 
for patients to tolerate the multiple required needle passes through 
the perineal skin. Due to recent technical advances TP-Bx may 
now be safely performed under local anesthesia.  
Primary Objective: 
To compare infection adverse events of TP-Bx vs. TR-Bx 
performed under local anesthesia. 
Secondary Objectives: 
To compare other adverse events such as bleeding and urinary 
retention. To compare detection rates of clinically significant and 
insignificant prostate cancer. 
SCHEMA 


 
Table of Contents 
1. STUDY OBJECTIVES ........................................................................................................... 7 
2. BACKGROUND .................................................................................................................... 7 
3. SUBJECT SELECTION ......................................................................................................... 8 
3.1 Study Population ............................................................................................................. 8 
3.2 Inclusion Criteria .............................................................................................................. 8 
3.3 Exclusion Criteria ............................................................................................................. 8 
4. STUDY PROCEDURES ......................................................................................................... 9 
4.1 Study Enrollment and Randomization .................................................................................. 9 
4.2 Data Collection & Confidentiality ....................................................................................... 10 
4.3 Study Calendar ............................................................................................................. 11 
4.4 Antibiotic Administration .................................................................................................. 12 
4.5 Biopsy Procedure .......................................................................................................... 12 
4.6 Duration of Follow Up ..................................................................................................... 12 
5. MEASUREMENT OF OUTCOMES ........................................................................................ 13 
5.1 Adverse events.............................................................................................................. 13 
5.2 Pain, Anxiety and Discomfort ........................................................................................... 14 


5.3 Biopsy Pathology ........................................................................................................... 14 
6. STATISTICAL CONSIDERATIONS ........................................................................................ 15 
 
1. 
Study Objectives 
Primary Objective: The primary objective of this study is to compare the incidence and severity 
of infectious complications between the transperineal and transrectal approaches to prostate 
biopsy. 
Secondary Objectives: Secondary objectives of this study include comparing the incidence of 
other adverse events, associated pain, and cancer detection rates between the transperineal 
and transrectal approaches. 
2. 
Background 
Approximately one million transrectal prostate biopsies (TR-Bx) are performed annually in the 
United States.1 The number of prostate Bx is expected to increase due to the demographic 
growth of the aging male population. Moreover, 44% of U.S. men undergoing initial biopsy 
report having a repeat biopsy within five years.2 Additionally, more than half of men diagnosed 
with prostate cancer currently opt for active surveillance, which requires serial repeat biopsy to 
monitor for disease progression.3 Therefore, biopsy use will only increase with greater adoption 
of active surveillance and the greater number of aging men. The safety and effectiveness of this 
common procedure will impact 1 out of 3 U.S. men at least once during their lifetimes when they 
undergo biopsy.  
Due to the need for biopsy needles to pass through the rectal mucosa on their trajectory to the 
prostate, TR-Bx is associated with a significant risk of infectious complications. The needle 
travels through the “dirty” rectal mucosa to the “clean” prostate at least 12 times,4 and fecal flora 
may seed the vascular prostate gland and bloodstream, leading to infection.5,6 One systematic 
review suggests this rate may be as high as 5%.7  The United States Preventive Services Task 
Force (USPSTF) Grade C recommendation for PSA screening considered adverse events 
associated with biopsy among the harms of PSA-based screening.8 Despite antibiotic 
prophylaxis, 44% of men experience bacteriuria and 16% experience bacteremia after TR-Bx.9  
Furthermore, the risk of post-biopsy infection has increased in recent years due to the growing 
incidence of antibiotic resistance.10 Nam first reported an alarming four-fold, population-based 
increase in post-Bx infection hospital admissions from 0.6% in 1996 to 3.6% in 2005 among  
75,190 patients.11 In particular, men with fluoroquinolone-resistant bacteria in the rectum are at 
increased risk for post-Bx infection and sepsis,12 which can result in dire complications such as 
limb gangrene/amputation, endocarditis, meningitis, disseminated intravascular coagulation 
(DIC) or death.13–18  
As an alternative to the transrectal approach, prostate biopsy may be performed percutaneously 
through the perineal skin. Due to avoidance of the rectum, transperineal prostate biopsy (TP-Bx) 
is associated with an overall lower risk of infectious complications. At some centers, this has 
obviated the need for perioperative antibiotics, which is reinforced by the Society of  
Interventional Radiology Guidelines. 19,20 One additional benefit of TP-Bx is that this procedure 
offers better sampling of the anterior prostate, which is missed with the transrectal approach in 
men with larger prostate volumes due to benign prostatic hyperplasia.21 The biopsy core 
excursion is 2 cm, and therefore sampling of the anterior prostate from the rectum is limited. In 
contrast, the TP approach has relative ease of access to the anterior prostate.6 This is reflected 


in greater detection of clinically significant prostate cancer in retrospective studies with 
transperineal22–25 under general anesthesia (49%-91%) vs. transrectal24,26–31 Bx approaches (14-
42%). Given more than 80% of first-time biopsy nationally are performed without 
MRItargeting,32,33 the utility of in-office transperineal vs. transrectal MRI-targeted biopsy must be 
evaluated as this applies to a large population of men. For instance, the American Urological 
Association professional guidelines were updated to recommend MRI use for first-time biopsy in 
early 2020;34 however, lack of insurance coverage and limited access for urologists to the costly 
MRI-targeted biopsy platform contribute to a large population of men who need to be evaluated 
in the repeat biosy setting of active surveillance and prior negative biopsy.  
Despite the aforementioned benefits of TP-Bx, this procedure has seen limited adoption due to 
the historic need for it to be performed under general anesthesia in order for patients to tolerate 
the required multiple needle sticks to the perineal skin. Additionally, because of the need for 
biopsy needles to traverse the pelvic floor muscles and vascular prostate apex, TP-Bx is 
believed to have a higher risk for urinary retention and bleeding as compared to the traditional 
transrectal approach.  
In recent years, the development of novel local anesthetic techniques and needle guides has 
permitted TP-Bx to be performed in the office setting with a more favorable side-effect 
profile.20,35,36 There has, however, been slow adoption of this procedure by only a handful of 
centers. In fact, national estimates of TP-Bx use place this figure closer to approximately 1-2%.  
In this study, we aim to compare the safety, tolerability, and cancer detection rates of TP-Bx 
versus TR-Bx within the contexts of a randomized clinical trial. The results of this study will 
provide high level medical evidence regarding which method of prostate biopsy carries the best 
risk to benefit ratio for men undergoing evaluation for prostate cancer.   
3. 
Subject Selection 
3.1 Study Population 
This study will include all men who are recommended to undergo prostate biopsy as part of 
routine clinical care. Inclusion and exclusion criteria are listed in the following sections. 
3.2 Inclusion Criteria 
• 
Male sex 
• 
Age ≥18 years 
• 
Active surveillance cohort: History of Grade Group 1 or 2 prostate cancer, first diagnosed  
prior to date of planned biopsy   
• 
Prior negative cohort: Clinical concern for the presence of prostate cancer as determined 
by the treating urologist and prior negative prostate biopsy ≤36 months prior to date of 
planned biopsy 
• 
Men without previous prostate biopsy (first time prostate biopsy) 
• 
Willingness to sign informed consent and adhere to the study protocol 
3.3 Exclusion Criteria  
• 
Acute prostatitis within the last 6 months 
• 
PSA > 20 ng/mL in men who have previously undergone prostate biopsy  
• 
Current non-urologic bacterial infection requiring active treatment with antibiotics 
• 
Unfit to undergo prostate biopsy under local anesthesia  


• 
Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland 
ablation 
• 
Men who have previously undergone prostate biopsy in whom artifact would reduce 
quality of prostate MRI (extensive orthopedic pelvic metal)  
• 
Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in 
men who have previously undergone prostate biopsy 
4. 
Study Procedures 
4.1 Study Enrollment and Randomization 
Eligible patients will be informed of the study by the study urologist and research staff.  
Interested participants may also learn more about the study through online resources such as 
ClinicalTrials.gov or through study informational brochures. All potential subjects will be allowed 
as much time as needed to consider study participation. Patients choosing to participate in the 
study will be consented within the privacy of a clinical exam room. Study staff will explain to 
each potential subject the research objectives, risks and benefits of study participation, and the 
subjects’ rights and responsibilities. For patients who are scheduled for biopsy, electronic 
consent will also be available via phone. Eligible patients will be contacted by a member of the 
study team (i.e. investigator or research coordinator), who will explain the study to the patient. 
The patient will also receive a link to the electronic consent form via email or MyChart message. 
This study will utilize either a traditional one-stage or a two-stage consent process. The reason 
for having the one-stage consent is there are a few sites in which the predominant approach is 
transperineal. Therefore, this two-stage consent does not work. With the one-stage consent,  
patients give permission to participate in the study prior to randomization (tradtional RCT 
consent). With a second-stage consent, subjects who meet all eligibility criteria will sign the 
firststage consent form. Patients will have the option to sign the consent in person or 
electronically. First-stage consent will register the subject to the study and will allow 
investigators to use their data from their medical record and post-biopsy questionnaire 
responses for research purposes. Subjects who sign first-stage consent will be randomized in a 
1:1 ratio to receive TP-Bx or TRBx. The patients’ first-stage consent or their traditional one-
stage consent will be valid for eight months to accommodate for biopsy scheduling. This will 
reduce the number of re-consents and align with the standard of care timeline for biopsy 
procedures. Biopsies are often scheduled as far out eight months from their clinic visit. 
Participants will be consented remotely using an electronic version of the informed consent form 
that follows federal, state, and local regulations, as applicable. We will implement the following 
procedures for electronic informed consent. 
The informed consent document(s) will be sent to the subject or their Legal Authorized 
Representative (LAR), if applicable, via secure email sent by REDCap prior to the scheduled 
consent discussion. The subject or LAR will be asked to review the consent document prior and 
during the consent discussion with a study staff member via phone or approved 
teleconferencing service (i.e., Zoom). The study staff member will confirm the subject or LAR 
has read and has the capacity to appreciate all aspects of the information presented in the 
consent process for the research study. The subject or LAR will be encouraged to ask 
questions. If agreeing to participate, the subject or LAR will sign the consent form using 
electronic informed consent (eConsent) via REDCap. A computer, tablet or touch screen phone 
will be used to capture digital signatures. The person conducting consent will also sign the 
electronic informed consent (eConsent) document in a contemporaneous manner. Subjects will 


be provided with a digital copy of the completed form via email. The informed consent 
discussion and process will be documented by the study team in the subject’s medical record or 
study record. 
If a subject does not have access to a touch screen phone, computer or tablet, cannot work with 
remote electronic informed consent, or the remote electronic informed consent cannot be 
obtained for any other reasons, the consent may be conducted and documented at an in-person 
visit prior to study activities via paper consent form or through REDCap on an ITS tagged 
device. 
The assignment sequence will use randomly permuted blocks of unequal size stratified by 
urologist, PSA (<4, 4-9.9, ≥10 ng / mL) and biopsy indication (prior negative vs. active 
surveillance) and implemented by the randomization model in REDCap, which prevents an 
investigator from learning allocation before a patient is unambiguously registered on study and 
from changing allocation afterwards, thus ensuring full allocation concealment. For men with 
prior biopsy, we exclude men with a PSA >20 ng/mL.  
For the REDCap randomization model, randomization of subjects will occur on the data 
collection form where the randomization field is located. Before a subject is randomized, a 
'Randomize' button will appear next to that field. When a user (who has been given appropriate 
'Randomize' user privileges) clicks that button, a pop-up box will appear that will allow the user 
to randomize the subject. After a subject has been randomized, the grouping (i.e. transrectal or 
transperineal biopsy) will become permanently locked and unmodifiable. The randomization field 
will always be locked and unmodifiable both before and after randomization has occurred for a 
subject.  
Randomization is unblinded, and research coordinators of respective enrolling sites will inform 
their patients of the assigned cohort. 
Subjects randomized to TR-Bx will receive transrectal biopsy. Subjects randomized to TP-Bx will 
undergo a second consent discussion with the enrolling investigator, where the risks and 
benefits of transperineal biopsy will be explained. Subjects can then decide whether to undergo 
standard transrectal biopsy or transperineal biopsy. Subjects who agree to undergo TP-Bx will 
sign the second-stage consent form.  
4.2 Data Collection & Confidentiality 
Study data will be prospectively collected from patient medical records and patient surveys. In 
all participating centers, the site-specific research coordinator will perform baseline data 
acquisition and medical record abstraction. This data will be entered into standardized clinical 
report forms housed within a REDCap environment and hosted by WCM. Each patient will be 
assigned a unique study identifier. 
REDCap (Research Electronic Data Capture) is a secure, web-based application designed 
exclusively to support data capture for research studies. The REDCap platform will be 
partitioned to permit read/write access only to site-specific records such that individual sites will 
be able to access records for their own subjects, exclusively. REDCap has a secure email and 
web-based data collection interface that may be utilized for collecting data. The site-specific 
research coordinator will determine individual patients’ preferred method of survey response 


and may collect survey data either through mail, telephone, REDCap, or during an in-person 
visit. 
Only the WCM research coordinator will be able to review de-identified data across sites to 
conduct data quality checks and share data quality with the study biostatistician.  
To ensure accuracy of data entered in the REDCap database from source documents (including 
surveys and medical record abstract), sites will perform 100% visual review and conduct double 
data entry for a sample (i.e., 10%) of the data. 
Data quality checks will be conducted every 6 months, coinciding with Data Safety and 
Monitoring reviews.  
For protocol deviations fitting immediately reportable criteria, the DSMC’s primary concern lies 
with whether the deviation has the potential to negatively impact subject safety or integrity of 
study data or whether the deviation places subjects at greater risk of harm (including physical, 
psychological, economic or social harm). If the DSMC makes determinations that the reported 
protocol deviation impacts either, it may recommend modifications, suspension or termination of 
the study.    
Interim study findings will be communicated in cases where modifications are recommended. 
The DSMC will require the PI to submit confirmation to the DSMC that the modification(s) have 
been made, or to submit a reason why the PI did not agree with the DSMC’s recommendation. 
4.3 Study Calendar 
 
Month -8 to Day 
0 
Day 0 
Day 5 to 9 
Eligibility  
Xa 
 
 
Informed consent 
X 
 
 
Demographics 
X 
 
 
Medical historyb 
X 
 
 
Physical examc 
X 
 
 
Randomization 
X 
 
 
PSA 
X 
 
 
Rectal swabd 
X 
 
 
Prostate Biopsy 
 
X 
 
Assessment of Adverse Eventse 
 
 
X 
Concomitant Medicationsf 
 
X 
X 


aTo be performed prior to informed consent. bMedical comorbidities, indication for biopsy, 
multiparametric MRI findings, and history of prior biopsy or infection. cHeight and weight. 
dfor transrectal biopsy only. 
eAssessed by patient questionnaire. Events will be grading using Common Terminology 
Criteria for Adverse Events (CTCAE) v5.0. fAssessed by patient quaestionnaires. 
4.4 Antibiotic Administration 
For patients undergoing a TR-Bx, antibiotic prophylaxis will be administered in accordance with 
guidelines from the American Urological Association (AUA).37 No antibiotic prophylaxis will be 
administered for patients undergoing a TP-Bx. 
4.5 Biopsy Procedure 
A meeting of study investigators will take place before recruitment to review and ensure 
standardization of biopsies approaches. Investigators will follow the technique described by Kubo 
et al. to administer lidocaine during TP-Bx.20 For both transperineal and transrectal approaches, 
20 mL of 1% lidocaine will be used, respectively, to standardize local anesthesia. At each site, 
however, the choice of commercial MRI-targeted biopsy platform will be left to the physicians’ 
discretion.  
In both transperineal and transrectal biopsy arms for MRI-targeted biopsy, the number of 
systematic biopsy cores will be standardized to 12 cores. The technique for TR-Bx is performed 
as described by Kasivisvanathan et al.22 A total of 12 systematic biopsy cores will be obtained 
from the peripheral zone of the prostate at the base, mid gland, and apex. Locations of the 12 
systematic cores are: Right lateral base, Right lateral midgland, Right lateral apex, Right medial 
base, Right medial midgland, Right medial apex, Left lateral base, Left lateral midgland, Left 
lateral apex, Left medial base, Left medial midgland, and Left medial apex. The technique for 
TPBx is performed as described by Urkmez et al.38. Locations of the systematic cores will be 
obtained as follows: 2 cores each at Right posterior lateral, Right posterior medial, Left posterior 
lateral, and Left posterior medial, as well as 1 core each at Right anterior lateral, Right anterior 
medial, Left anterior lateral, and Left anterior medial. 
In both transperineal and transrectal biopsy arms, the number of targeted biopsy cores will be 
standardized to 3 cores per target, with a maximum of three ROIs permitted to be chosen for 
targeted biopsy. MRI-targeted biopsy registration (i.e., matching of the image of the target on MRI 
with the real-time image of the prostate during biopsy) may be performed by means of visual 
registration or software-assisted registration. 
De-identified video capture of each site’s first 10 TP-Bx and TR-Bx will be distributed for review 
among investigators to monitor for variation in biopsy technique. Deviations from the technique 
that may occur during routine clinical care will be recorded for each case, monitored by the WCM 
DSMC and compared between groups. Research coordinators at each site will randomly select 3 
TP-Bx and 3 TR-Bx for video upload every 3 months. Investigators will review and discuss during 
quarterly video-conferences to ensure consistent procedural fidelity throughout the study. 
4.6 Duration of Follow Up 
Patients will be followed for approximately 7 days following biopsy to evaluate for adverse 
events. Subjects experiencing an adverse event beyond 7 days stabilization will be followed 
until resolution or stabilization. 


5. 
Measurement of Outcomes 
5.1 Adverse events 
The primary objective of this study is to compare the incidence and severity of infectious 
complications experienced by patients undergoing TP-Bx versus TR-Bx. Patients will be 
assessed for complications by way of electronic questionnaire administered 7±2 days post 
biopsy using a REDCap site hosted at Weill Cornell Medical Center. For patients unable to 
complete the questionnaire electronically, responses will be obtained via telephone interview. 
Any patient indicating that they experienced an adverse event will be contacted by the study 
team to seek further details. Additionally, all relevant medical records will be requested. Adverse 
events will be classified in accordance with Common Terminology Criteria for Adverse Events 
(CTCAE) v5.0.  
The primary outcomes are infection rates of TP-Bx versus TR-Bx.  
The secondary outcomes are patient-reported pain and anxiety, and comparison of 
noninfectious complications such as bleeding and urinary retention rates, and cancer detection. 
Timing for assessment of study variables. 
Assessment 
Baseline 
Pre-Bx 
Day 
of Bx 
7-days  
Post-Bx 
Baseline history and physical 
exam, screening, consent 
✓ 
Prior Bx (Y/N) 
✓ 
Prior Bx infection (Y/N) 
✓ 
PSA  
✓ 
Indication for Bx 
✓ 
MpMRI findings 
✓ 
Randomization: TR-Bx vs. TP-Bx 
✓ 
Bx infection risk determination for 
TR-Bx prophylaxis 
✓ 
Bx completed (Y/N) 
✓ 
Bx duration (minutes) 
✓ 
Pain (VAS) 
✓ 
✓ 
Discomfort (VAS) 
✓ 
✓ 
TMI Anxiety (Likert 5 levels) 
✓ 
Decision regret 
✓ 
Adverse events (Y/N) and Bother 
UTI 
✓ 
Sepsis 
✓ 
Urinary retention 
✓ 


Fever 
✓ 
Hematuria 
✓ 
Hematochezia 
✓ 
Hematospermia 
✓ 
UTI diagnosed by HCP 
✓ 
Unplanned HCP contact  
✓ 
Qualitative responses 
✓ 
Bx pathologic outcomes, if cancer: 
✓ 
Gleason grade group(s) 
✓ 
Number of cores positive 
✓ 
Number of cores negative 
✓ 
Maximum cancer core length 
✓ 
Targeted Bx positive (Y/N/NA) 
✓ 
Systematic Bx positive (Y/N) 
✓ 
Location of positive cores 
✓ 
5.2 Pain, Anxiety and Discomfort  
A questionnaire will be given to patients immediately after the biopsy and at 7±2 days post-biopsy 
(Appendix). The questionnaire captures discomfort and pain and fear-anxiety using a numerical 
rating scale (0-10), with higher scores indicating greater intensity of symptoms. The questionnaire 
also asks about the presence or absence of adverse events, with reporting of significant adverse 
events (fever, chills, urinary retention, urinary tract infection, treatment from a doctor) subject to 
follow-up from study staff. 
Infectious complications will be captured as: (1) uncomplicated urinary tract infection (UTI): 
dysuria, urgency, frequency or hematuria without fever and with or without pyuria (>5 white 
blood cells per high-powered field or positive leukocyte esterase on urine dipstick) or bacteriuria 
(≥ 105 colony-forming units/mL); (2) complicated UTI: fever, flank pain, nausea or vomiting with 
or without pyuria and bacteriuria; (3) urosepsis: criteria for sepsis, severe sepsis, and septic 
shock39  were combined and categorized as urosepsis.40  
5.3 Biopsy Pathology 
The proportion of men diagnosed with clinically significant cancer and clinically insignificant 
cancer will be compared by biopsy approach. Detection of prostate cancer will be captured from 
the final pathology report. We will record the prostate cancer grade, number and location of 
positive biopsies for transrectal (location: left vs. right, medial vs. lateral, apex, mid, and base) 
and for transperineal (location: posterior medial, posterior lateral, and anterior), as well as the 
maximum cancer core length (in mm), and total number of negative cores. In order to compare 
outcomes, prostate cancer grade will be categorized into insignificant (Gleason grade group 1) 
and clinically significant (grade group ≥ 2).22  


6. 
Statistical Considerations 
We define infection complication as any of the following: (1) fever requiring medical advice or 
intervention; (2) chills requiring medical advice or intervention; or (3) UTI diagnosed by healthcare 
professional.41 We aim to enroll 1,702 (n=682 active surveillance, n=620 prior negative biopsy, n 
=400 first time biopsy) subjects in this study, with equal randomization between groups. We 
assume that the infection rate in the transperineal group is 0.5%. Given a one-sided α of 0.10, the 
power to reject the null hypothesis of no difference in infection rates will be >80% if the event rate 
in the transrectal group is 2.0%. The event estimate is consistent with published post-transrectal 
biopsy infection rates range from 1% to 17.5%41–49 and the 2017 AUA prostate biopsy guidelines 
cite an infection risk of 5-7%.37 
Analysis of infection, detection of clinically significant cancer (i.e. Grade Group 2+), over-detection 
of clinically insignificant cancer (i.e. Grade Group 1), presence vs. absence of other biopsy related 
complication grade 2 or above and, separately, Grade 1 (patient-reported hematuria, 
hematospermia or hematochezia) will be by logistic regression with site and prior negative vs. 
active surveillance as fixed effect covariates. The Barnard's test will be used to analyze the data. 
Absolute risk differences will be calculated by applying the odds ratio from the regression to the 
prevalence in the transrectal group, with 95% CI obtained by bootstrapping. As a sensitivity 
analysis for high-grade cancers missed on biopsy, we will include as an event any detection of 
grade group ≥2 cancer up to two years after randomization, whether detected by subsequent 
biopsy or upgrading on surgical pathology, as a binary variable. We will also explore whether the 
relative effects of transperineal biopsy on cancer detection varies by race or diagnostic setting 
(active surveillance vs. prior negative) by adding race (African ancestry yes or no) or setting  
(active surveillance vs. prior negative) and the associated interaction terms in two separate 
logistic regression models. 
Rates of missing data are expected to be extremely low because all outcomes are assessed within 
a short period of time after biopsy. Hence, we do not anticipate having to use statistical methods 
to handle missing data. However, if rates of missing data are more than 5%, we will implement 
multiple imputation using chained equations. 
To compare the detection of clinically significant cancer biopsy with systematic vs. MRI-targeted 
biopsy, stratified by transperineal vs. transrectal, the analyses will be conducted separately for the 
prior negative biopsy and active surveillance cohorts separately. For the prior negative biopsy 
patients, we will create a model with the outcome of clinically significant cancer and predictors of 
the linear predictor from the standard Prostate Biopsy Collaborative Group model plus PI-RADS 
version 2 MRI score and MRI prostate volume.50 For the active surveillance cohort, we will use a 
similar approach but use the Canary “base” model for biopsy outcome in active surveillance 
patients.51 We will report the increase in discrimination associated with using MRI volume and 
PIRADS score and conduct decision curve analysis, a decision-analytic technique that weighs the 
value of avoiding unnecessary biopsy compared to missing high-grade cancer, to assess the  
clinical utility of the models.52  
 


  
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Cooperberg MR, Carroll PR. Trends in Management for Patients With Localized Prostate 
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Mosharafa AA, Torky MH, El Said WM, Meshref A. Rising incidence of acute prostatitis 
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Carlson WH, Bell DG, Lawen JG, Rendon RA. Multi-drug resistant E.coli urosepsis in 
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Toren P, Razik R, Trachtenberg J. Catastrophic sepsis and hemorrhage following 
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Al-Otaibi MF, Al-Taweel W, Bin-Saleh S, Herba M, Aprikian AG. Disseminated 
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Borer A, Gilad J, Sikuler E, Riesenberg K, Schlaeffer F, Buskila D. Fatal Clostridium 
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transrectal prostate biopsy. J Infect. 1999;38(2):128-129. 
17. 
Erdogan H, Ekinci MN, Hoscan MB, Erdogan A, Arslan H. Acute bacterial meningitis after 
transrectal needle biopsy of the prostate: a case report. Prostate Cancer Prostatic Dis. 
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18. 
Dunfield L, Usman A, Fitzpatrick-Lewis D. Screening for prostate cancer with prostate 
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a systematic review of the clinical benefits and harms. Ottawa: Canadian Task Force on 
Preventive Health Care. Published online 2013. 
19. 
Venkatesan AM, Kundu S, Sacks D, et al. Practice guidelines for adult antibiotic 
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Kubo Y, Kawakami S, Numao N, et al. Simple and effective local anesthesia for 
transperineal extended prostate biopsy: application to three-dimensional 26-core biopsy. 
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21. 
Meyer AR, Mamawala M, Winoker JS, et al. Transperineal Prostate Biopsy Improves the  
Detection of Clinically Significant Prostate Cancer among Men on Active Surveillance. J  
Urol. 2021;205(4):1069-1074. doi:10.1097/JU.0000000000001523 
22. 
Kasivisvanathan V, Dufour R, Moore CM, et al. Transperineal magnetic resonance image 
targeted prostate biopsy versus transperineal template prostate biopsy in the detection 
of clinically significant prostate cancer. J Urol. 2013;189(3):860-866. 
doi:10.1016/j.juro.2012.10.009 
23. 
Radtke JP, Kuru TH, Boxler S, et al. Comparative analysis of transperineal template 
saturation prostate biopsy versus magnetic resonance imaging targeted biopsy with 
magnetic resonance imaging-ultrasound fusion guidance. J Urol. 2015;193(1):87-94. 
doi:10.1016/j.juro.2014.07.098 


24. 
Huang H, Wang W, Lin T, et al. Comparison of the complications of traditional 12 cores 
transrectal prostate biopsy with image fusion guided transperineal prostate biopsy. BMC 
Urol. 2016;16(1):68. doi:10.1186/s12894-016-0185-z 
25. 
Hansen NL, Kesch C, Barrett T, et al. Multicentre evaluation of targeted and systematic 
biopsies using magnetic resonance and ultrasound image-fusion guided transperineal 
prostate biopsy in patients with a previous negative biopsy. BJU Int. 
2017;120(5):631638. doi:10.1111/bju.13711 
26. 
Siddiqui MM, Rais-Bahrami S, Turkbey B, et al. Comparison of MR/ultrasound 
fusionguided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. 
JAMA.  
2015;313(4):390-397. doi:10.1001/jama.2014.17942 
27. 
Pokorny MR, de Rooij M, Duncan E, et al. Prospective study of diagnostic accuracy 
comparing prostate cancer detection by transrectal ultrasound-guided biopsy versus 
magnetic resonance (MR) imaging with subsequent MR-guided biopsy in men without 
previous prostate biopsies. Eur Urol. 2014;66(1):22-29. 
doi:10.1016/j.eururo.2014.03.002 
28. 
Quentin M, Blondin D, Arsov C, et al. Prospective evaluation of magnetic resonance 
imaging guided in-bore prostate biopsy versus systematic transrectal ultrasound guided 
prostate biopsy in biopsy naïve men with elevated prostate specific antigen. J Urol.  
2014;192(5):1374-1379. doi:10.1016/j.juro.2014.05.090 
29. 
Arsov C, Rabenalt R, Blondin D, et al. Prospective randomized trial comparing magnetic 
resonance imaging (MRI)-guided in-bore biopsy to MRI-ultrasound fusion and transrectal 
ultrasound-guided prostate biopsy in patients with prior negative biopsies. Eur Urol.  
2015;68(4):713-720. doi:10.1016/j.eururo.2015.06.008 
30. 
Sonn GA, Margolis DJ, Marks LS. Target detection: magnetic resonance 
imagingultrasound fusion-guided prostate biopsy. Urol Oncol. 2014;32(6):903-911. 
doi:10.1016/j.urolonc.2013.08.006 
31. 
Filson CP, Natarajan S, Margolis DJA, et al. Prostate cancer detection with magnetic 
resonance-ultrasound fusion biopsy: The role of systematic and targeted biopsies. 
Cancer. 2016;122(6):884-892. doi:10.1002/cncr.29874 
32. 
Liu W, Patil D, Howard DH, et al. Impact of prebiopsy magnetic resonance imaging of the 
prostate on cancer detection and treatment patterns. Urol Oncol. 2019;37(3):181.e15-
181.e21. doi:10.1016/j.urolonc.2018.11.004 
33. 
Rosenkrantz AB, Hemingway J, Hughes DR, Duszak R, Allen B, Weinreb JC. Evolving 
use of prebiopsy prostate magnetic resonance imaging in the medicare population. J 
Urol. 2018;200(1):89-94. doi:10.1016/j.juro.2018.01.071 
34. 
Bjurlin MA, Carroll PR, Eggener S, et al. Update of the standard operating procedure on 
the use of multiparametric magnetic resonance imaging for the diagnosis, staging and 


management of prostate cancer. J Urol. 2020;203(4):706-712. 
doi:10.1097/JU.0000000000000617 
35. 
Meyer AR, Joice GA, Schwen ZR, Partin AW, Allaf ME, Gorin MA. Initial Experience 
Performing In-office Ultrasound-guided Transperineal Prostate Biopsy Under Local 
Anesthesia Using the PrecisionPoint Transperineal Access System. Urology.  
2018;115:8-13. doi:10.1016/j.urology.2018.01.021 
36. 
Perineologic, Allaway MJ. Perineologic. Accessed August 5, 2018.  
https://perineologic.com/ 
37. 
Liss MA, Ehdaie B, Loeb S, et al. An update of the American Urological Association white 
paper on the prevention and treatment of the more common complications related to 
prostate biopsy. J Urol. 2017;198(2):329-334. doi:10.1016/j.juro.2017.01.103 
38. 
Urkmez A, Demirel C, Altok M, Bathala TK, Shapiro DD, Davis JW. Freehand versus 
Grid-Based Transperineal Prostate Biopsy: A Comparison of Anatomical Region Yield 
and Complications. J Urol. 2021;206(4):894-902. doi:10.1097/JU.0000000000001902 
39. 
Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus 
Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801-810. 
doi:10.1001/jama.2016.0287 
40. 
Zembower TR, Maxwell KM, Nadler RB, et al. Evaluation of targeted antimicrobial 
prophylaxis for transrectal ultrasound guided prostate biopsy: a prospective cohort trial. 
BMC Infect Dis. 2017;17(1):401. doi:10.1186/s12879-017-2470-1 
41. 
Rosario DJ, Lane JA, Metcalfe C, et al. Short term outcomes of prostate biopsy in men 
tested for cancer by prostate specific antigen: prospective evaluation within ProtecT 
study. BMJ. 2012;344:d7894. doi:10.1136/bmj.d7894 
42. 
Lundström K-J, Drevin L, Carlsson S, et al. Nationwide population based study of 
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2014;192(4):11161122. doi:10.1016/j.juro.2014.04.098 
43. 
Bruyère F, Malavaud S, Bertrand P, et al. Prosbiotate: a multicenter, prospective analysis 
of infectious complications after prostate biopsy. J Urol. 2015;193(1):145-150. 
doi:10.1016/j.juro.2014.07.086 
44. 
Wagenlehner FME, van Oostrum E, Tenke P, et al. Infective complications after prostate 
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and 2011, a prospective multinational multicentre prostate biopsy study. Eur Urol.  
2013;63(3):521-527. doi:10.1016/j.eururo.2012.06.003 
45. 
Loeb S, van den Heuvel S, Zhu X, Bangma CH, Schröder FH, Roobol MJ. Infectious 
complications and hospital admissions after prostate biopsy in a European randomized 
trial. Eur Urol. 2012;61(6):1110-1114. doi:10.1016/j.eururo.2011.12.058 


46. 
Chambó RC, Tsuji FH, Yamamoto HA, Jesus CMN de. Short-term prophylaxis with 
ciprofloxacin in extended 16-core prostate biopsy. Int Braz J Urol. 2015;41(1):46-56. 
doi:10.1590/S1677-5538.IBJU.2015.01.08 
47. 
Unnikrishnan R, El-Shafei A, Klein EA, Jones JS, Kartha G, Goldman HB. For single 
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48. 
Abughosh Z, Margolick J, Goldenberg SL, et al. A prospective randomized trial of 
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guided prostate biopsy. J Urol. 2013;189(4):1326-1331. doi:10.1016/j.juro.2012.09.121 
49. 
Park DS, Hwang JH, Choi DK, et al. Control of infective complications of transrectal 
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50. 
Ankerst DP, Straubinger J, Selig K, et al. A contemporary prostate biopsy risk calculator 
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APPENDIX 
Immediate post biopsy questionnaire 
Please ask the patient to fill this out after the biopsy, before they leave the department. 
Please check the box corresponding to the number, which describes how you felt 
immediately after the biopsy procedure: 
1. Overall, how much discomfort did the biopsy procedure cause you? 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
No discomfort 
        Moderate discomfort 
            Extreme discomfort 
2. Overall, how much pain did the biopsy procedure cause you? 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
No pain 
           Moderate pain 
                     Extreme pain 
3. Overall, how much fear/anxiety did the biopsy procedure cause you? 


0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
No fear or anxiety 
   Moderate fear or anxiety 
     Extreme fear or anxiety 
4. Please list any medications that you are currently taking. An example is given in the first 
box: 
Name of 
medication 
Dosage 
Number 
of 
doses per day 
Start Date 
End Date 
Indication 
e.g. ciprofloxacin 
500mg 
2 
09/29/2021 
10/06/2021 
Infection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thank you for completing the questionnaire. Please hand this to the research 7-
day post biopsy questionnaire 
1. Overall, how much discomfort  do you have from the biopsy? 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
No discomfort 
       Moderate discomfort 
            Extreme discomfort 
2. Do you have pain at the site where the biopsy was taken? 
 
Yes 
No     
 
3. If Yes, how much pain are you having at the biopsy site? 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
No pain 
        Moderate pain 
       Extreme pain 


Did you experience the following problems during the 7 days after the biopsy procedure? 
 
1. Fevers 
 
 
Yes 
No     
 
5. Blood in the stools (“poop”) 
 
Yes 
No     
 
6. Acute urinary retention, meaning being unable to pass urine (“pee”) which was relieved by 
putting a catheter into the bladder through the penis 
 
Yes 
No     
 
7. Urinary tract infection diagnosed by a healthcare professional (doctor or nurse) 
 
Yes 
No     
 
8. Please list any new medications, especially any painkillers or antibiotics, that you have 
taken since the biopsy. Do not list your regular medications but do list any new medications 
started related to the biopsy. Only list the medications if you have taken them. An example is 
given in the first box: 
Name of medication 
Dosage 
Number of doses per day 
Number of days 
Yes 
No     
2 .Shivering and/or chills, as if you had a flu 
Yes 
No     
3 .Blood in the urine (“pee” ) 
Yes 
No     
4 .Blood in the semen (ejaculate or “cum” ) 


e.g. ciprofloxacin 
500mg 
2 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9. Since the biopsy, have you had contacts with hospital services for reasons related to the 
biopsy, which were unplanned and not part of the routine study visits? 
Please answer yes if you have had any unplanned contact with any healthcare staff e.g. 
doctor, nurse, other. Please also answer yes if you have had any unplanned consultations 
with healthcare staff over the phone: 
 
Yes 
No     
 
10. Since the biopsy, have you had contacts with the community healthcare team for reasons 
unrelated to the biopsy? 
Please answer yes if you have had any contact with any healthcare staff in the community 
e.g. GP, practice nurse, community nurse, other. Please also answer yes if you have had 
any consultations with community healthcare staff over the phone: 
 
Yes 
No     
 


Thank you for completing the questionnaire. Please contact us if you have any 
questions. 

ICF_000.pdf: 
Randomized controlled trial assessing transperineal prostate biopsy to reduce infec6on 
complica6ons  
 
NCT04843566 
 
ICF Approved 10/22/2021 


Version A, B, C, D dated 14-OCT-2021
BRANY ID #: 18-02-365
Page 1 of 10
BIOMEDICAL RESEARCH ALLIANCE OF NEW YORK LLC
 WEILL CORNELL MEDICINE
SUBJECT INFORMATION AND 
FIRST-STAGE INFORMED CONSENT FORM
Protocol Title: Randomized controlled trial assessing transperineal prostate biopsy to reduce 
infection complications
BRANY ID #:
18-02-365
Sponsor:
Weill Cornell Medicine
Principal Investigator:  Jim C. Hu, MD MPH
Institution:
Weill Cornell Medicine
Address: 
525 E 68th Street, Starr 946
New York, NY 10065
Telephone:
646.962.9600
KEY INFORMATION ABOUT THIS RESEARCH STUDY
You are being asked to be a subject in a research study because you have an indication to 
undergo a prostate biopsy as recommended by your physician. 
The following table is a concise and focused presentation of key information to assist 
you in understanding why you might or might not want to participate in the research.
Purpose
This is a research study to evaluate the comparative effectiveness 
and tolerability of outpatient transrectal prostate biopsy versus 
transperineal prostate biopsy, both MRI-targeted.
Consent Process
Typically when participating in a research study, all the information 
is provided upfront in one consent form. Instead, this is a two-step 
consent process that gives only information needed at the time.
This is the first stage of the consent process, where you are 
consenting to participate in a research study that allows us to track 
and compare prostate biopsy outcomes.
Experimental/ 
Investigational
You will not receive any experimental drugs or procedures as part of 
this study.
You will be randomly assigned to receive one of two comparable 
outpatient prostate biopsy procedures that are currently available.
If you are selected to receive the transrectal biopsy, there will be no 
further consent discussions related to this research and you will 
receive medical treatment as usual. You will also fill out research 
questionnaires, as described below.
If you are selected to receive the transperineal biopsy, we will talk to 
you about it then. You will decide at that point in time if you want to 
 
IRB APPROVED
10/22/2021


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BRANY ID #: 18-02-365
Page 2 of 10
have the transperineal biopsy. You do not have to have it if you do 
not want to. If you are selected for the new approach and decide to 
have it, you will sign another consent form at that time.
This second consent will discuss the risks and benefits and other 
information specific to the transperineal approach. You will never 
receive any treatment without us telling you about it first. You will 
always have the chance to say “Yes” or “No” to any treatment.
After the biopsy, you will fill out a questionnaire that asks about urinary 
and sexual function, and complications following the procedure. Your 
health information will be de-identified and stored by the hospital.
Voluntary Participation
Your decision to be in this study is voluntary.
Withdrawal
If you decide to be in this study and then change your mind, you can 
leave the study at any time without penalty. 
Length of Participation
Your participation in the study is expected to last up to 7 days. 
During that time, you will have 2 study visits: a screening visit and 
day of biopsy visit. You will also complete a questionnaire 
immediately after your biopsy and 7 days after biopsy.  
Procedures
The main procedures in the study include:

Transrectal prostate biopsy; or

Transperineal biopsy

Questionnaires
The study doctor will explain which procedures are being done for 
research, and which would be done as part of your standard care 
even if you don’t participate.
Risks 
Taking part in this research may expose you to risks (side effects). 
There are risks from study procedures. Side effects may range from 
being mild to life-threatening and may go away with treatment or be 
permanent. 
The common/main risks of the biopsy include:

Blood in urine, stool, and/or semen

Infection

Discomfort

Urinary retention

Bleeding due to accidental injury
The study doctor will explain the risks of this research to you before 
you decide about participation.
 
IRB APPROVED
10/22/2021


Version A, B, C, D dated 14-OCT-2021
BRANY ID #: 18-02-365
Page 3 of 10
Benefit
There is no guarantee that you will benefit as a result of your 
participation in this study, however the study results may help 
people in the future.
Alternative(s) to Study 
Participation
You do not have to participate in this study to receive treatment for 
your condition. The study doctor will discuss study alternatives with 
you and their risks and benefits.
Costs
Participation may result in costs to you, as applicable: 
You or your insurance company will be responsible for the cost of 
the biopsy performed within the study, as it falls within standard of 
care.
Confidentiality
There are provisions in place by the study protocol and study site to 
help protect the privacy and confidentiality of your personal health 
information and study information. 
This overview does not include all of the information you need to know before 
deciding whether or not to take part. Additional detail is given in the full consent 
document, which can be found on the pages that follow. Be sure to review the 
rest of this consent form before deciding about participation.
INFORMED CONSENT FORM
You are being asked to be a participant in a research study because you have an indication to 
undergo a prostate biopsy as recommended by your physician. This consent form explains the 
research study. Before you decide to be a part of this study, you need to know why the research 
is being done, what it will involve and the risks and benefits. Ask the study doctor and study staff 
to explain anything in this form or if you want more information. Please take time to read this 
form carefully. Feel free to discuss it with your relatives, friends and your primary care 
physician. 
You can choose to not participate in this study.  If you choose to participate in this research 
study, you can choose to withdraw from it at any time.  If you decide not to participate or you 
later choose to withdraw from participation, your decision will not affect your present or future 
medical care and there will be no penalty or loss of benefits to which you are otherwise entitled.
If you agree to take part in this research study, you will be asked to sign this consent form. 
DISCLOSURE OF FINANCIAL INTERESTS  
Weill Cornell Medicine, the sponsor of this study, is providing funds on a per subject basis for 
conducting this research study.  
PURPOSE OF THE STUDY
Doctors know a lot about the performing prostate biopsies. However, we are always trying to 
learn more and improve our skills for our patients’ benefit. We would like to try and make 
prostate biopsies safer, with less side effects for the patient and look for a better way to find 
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In this study, we will monitor if there are problems after a participant’s standard of care prostate 
biopsy. We will also document the results of the biopsy and patient-reported quality of life.
We are asking those individuals who join the study if we can offer them an alternative and 
comparable approach to prostate biopsy. Those who agree to participate may hear about this 
approach and decide whether they are interested. None of the changes we are considering 
have significant risks or involve large changes to the prostate biopsy.
NUMBER OF SUBJECTS AND LENGTH OF STUDY
About 1,702 subjects are expected to participate in this study at 12 research sites in the United 
States.   
Your participation in this study is expected to last 7 days.  
STUDY PROCEDURES
If you take part in this study, you agree to have your routinely collected clinical data used for research 
purposes. Questionnaires will be also administered immediately after your biopsy and during a 7 day 
follow up visit to assess symptoms after your procedure. 
Please advise your study doctor or their team of any medications you are taking.  In addition, if 
you are taking any over-the-counter drugs or herbal supplements which you have obtained from 
the drug store, grocery store, etc., you should advise the study doctor or their team.
As part of this study, you may be will be randomly assigned to receive one of two comparable 
outpatient prostate biopsy procedures that are currently available. Randomization means that you are 
put into a group by chance.  It is like flipping a coin.   Neither you nor the your study doctor will 
choose what group you will be in.  You will have a 1 in 2 chance of being placed in any group.
If you are selected to hear about the transperineal approach, we will talk to you about it then. You will 
decide at that point in time if you want to have it. You do not have to have it if you do not want to. If 
you are selected for the new approach and decide to have it, you will sign another consent form at 
that time.
This second consent will discuss the risks and benefits and other information specific to the 
alternative approach. You will never receive any treatment without us telling you about it first. You will 
always have the chance to say “Yes” or “No” to any treatment.
If you are selected for the transrectal approach, there will be no further discussions related to this 
research and your active participation on this study will end after you complete the post-biopsy 
questionnaires.
Clinically Relevant Results
If results of study procedures (e.g. blood tests, imaging scans) provide clinical information that 
may be important to your health care, you will be told about those results. 
PARTICIPANT RESPONSIBILITIES
As a participant in this study, you will have certain responsibilities, including the following:

Attend all study visits and, if needed, reschedule appointments as soon as possible

Follow the instructions of the study team

Check with the study doctor before taking any new medicines (including prescription, over-
the-counter, vitamins and herbal supplements)

Tell the study doctor or study staff any time you do not feel well or if you have any side 
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RISKS AND DISCOMFORTS
For research studies involving prostate biopsy, there may be risks. These risks will be discussed 
with you by the study doctor and/or your regular doctor.
Risks and side effects related to the prostate biopsy we are studying include:
Likely

Blood in semen (92.6%)

Blood in urine (65.8%)

Discomfort or pain during or following the procedure (43.6%)

Blood in stool (36.8%)
Possible

Infection – may range from urinary tract infection to sepsis, a potentially life-threatening 
condition caused by the body’s response to an infection (5% for transrectal; 0.1% for 
transperineal)

Urinary retention (1%)

Bleeding due to accidental injury (1%)
There may also be side effects, other than listed above that we cannot predict. Other drugs may 
be given to make side effects that occur less serious and less uncomfortable. Many side effects 
go away shortly after the prostate biopsy, but in some cases side effects can be serious, long 
lasting or permanent.
NEW INFORMATION
You will be notified in a timely manner if important new findings become known that may affect 
your willingness to continue in the study. 
For example, if we learn about new risks, we will share that information with you.  If we think you 
need to know quickly, the study doctor or their staff may call you. If we do not think you need to 
know quickly, we will tell you at your next visit.  If you still want to participate, we may ask you to 
sign a new consent form.    
BENEFITS
There is no guarantee that your condition will improve as a result of your participation in this 
study.  It may stay the same or worsen.  However, the information learned from this study may 
help other people with this disease in the future.
ALTERNATIVES TO STUDY PARTICIPATION
You do not have to participate in this study to receive treatment for your condition. Instead of 
being in this study, you have these options:

You may choose not to participate in this study.

You may choose a standard transrectal MRI-guided biopsy without being in the study.

You may choose a standard transperineal MRI-guided biopsy without being in the 
study.
The study doctor will discuss study alternatives with you and their risks and benefits.
 
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COSTS OF PARTICIPATION
Participation may result in costs to you, as applicable: 
You or your insurance company will be responsible for the cost of the biopsy performed within 
the study, as it falls within standard of care.
The costs of medications and the administration of these medications that you receive during 
this study will be charged to you or your insurance provider.
The physical examinations, standard laboratory tests, and diagnostic procedures such as the 
MRI scans involved in this study are considered part of the standard care for patients with your 
disease. The costs associated with each test will be charged to you or your insurance provider 
in the same manner as if you were not part of this research study. Therefore, you or your 
insurance provider will need to assume responsibility for these costs. You will be billed for all 
costs or co-payments that are not paid by your insurance provider.
Taking part in this study may lead to added costs for you or your insurance company. Please 
ask about any expected added costs or potential insurance problems. You may wish to consult 
with your insurance company in advance about whether insurance will pay for these costs.
You or your insurance company will be charged for continuing medical care and/or 
hospitalization that are not a part of the study.
REIMBURSEMENT
You will not be paid for participation in this study. 
You will not receive reimbursement or compensation for out-of-pocket study visit expenses such 
as travel, parking, and meals.
COMPENSATION FOR INJURY
We are obligated to inform you about WCM’s policy in the event injury occurs. If, as a result of
your participation, you experience injury from known or unknown risks of the research
procedures as described, immediate medical care and treatment, including hospitalization, if
necessary, will be available at the usual charge for such treatment. No monetary compensation
is available from WCM or NewYork-Presbyterian Hospital. For medical emergencies, call 911. 
No other compensation will be offered by Weill Cornell Medicine or the sponsor or Biomedical 
Research Alliance of New York for things such as lost wages, disability, or discomfort as part of 
this study.  
You are not waiving any legal right to seek additional compensation through the courts by 
signing this form.
CONFIDENTIALITY 
To the extent allowed by law, every effort will be made to keep your personal information 
confidential. However, information from this study will be submitted to the study sponsor and to 
the U.S. Food and Drug Administration. It may be submitted to governmental agencies in other 
countries where the study product may be considered for approval. Medical records, which 
identify you and the consent form signed by you, will be looked at by the sponsor or the 
sponsor’s representatives and may be looked at by the FDA and other regulatory agencies, the 
Institutional Review Board, and the Biomedical Research Alliance of New York. While these 
parties are aware of the need to keep your information confidential, total confidentiality cannot 
 
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be guaranteed. The results of this research project may be presented at meetings or in 
publications; however, you will not be identified in these presentations and/ or publications. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time.
AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION
Federal regulations give you certain rights related to your health information. These include the 
right to know who will be able to get the information and why they may be able to get it. The 
study doctor must get your authorization (permission) to use or give out any health information 
that might identify you. If you choose to be in this study, the study doctor will get personal 
information about you. This may include information that might identify you. The study doctor 
may also get information about your health, including:

Past and present medical records

Research records

Records about phone calls made as part of this research

Records about your study visits

Information obtained during this research about laboratory test results

Results from diagnostic and medical procedures including but not limited to X-rays, physical 
examinations and medical history

Billing records
Information about your health may be used and given to others by the study doctor and staff. 
They might see the research information during and after the study. Your information may be 
given to the sponsor of this research. “Sponsor” includes any persons or companies that are 
working for or with the sponsor, or are owned by the sponsor. Information about you and your 
health which might identify you may be given to: 

The U.S. Food and Drug Administration 

Department of Health and Human Services agencies

Governmental agencies in other countries

Biomedical Research Alliance of New York (BRANY)

The Institutional Review Board

Accrediting agencies

Data safety monitoring boards

Health insurers and payers
Your personal health information may be further shared by the groups above. If shared by them, 
the information will no longer be covered by the U.S. federal privacy laws. However, these 
groups are committed to keeping your personal health information confidential. If you give 
permission to give your identifiable health information to a person or business, the information 
may no longer be protected. There is a risk that your information will be released to others 
without your permission.
Information about you and your health that might identify you may be given to others to carry out 
the research study. The sponsor will analyze and evaluate the results of the study. In addition, 
people from the sponsor and its consultants will be visiting the research site. They will follow 
how the study is done, and they will be reviewing your information for this purpose. The 
information may be given to the FDA. It may also be given to governmental agencies in other 
countries. This is done so the sponsor can receive marketing approval for new products 
 
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resulting from this research. The information may also be used to meet the reporting 
requirements of governmental agencies.
This authorization does not have an expiration date. If you do not withdraw this authorization in 
writing, it will remain in effect indefinitely. 
By signing this consent form, you are giving permission to use and give out the health 
information listed above for the purposes described above. You do not have to sign this consent 
form. If you choose not to sign this consent form, you will not be able to be in this research 
study. Your decision not to sign this consent form will not have any effect on your medical care 
and you will not lose any benefits or legal rights to which you are entitled. You have the right to 
review and copy your health information. However, if you decide to be in this study and sign this 
permission form, you may not be allowed to look at or copy your information until after the 
research is completed.
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the study doctor at the address on the front of 
this informed consent form. If you withdraw your permission, you will not be able to continue 
being in this study, but you will not have any penalty or loss of access to treatment or other 
benefits to which you are entitled. When you withdraw your permission, no new health 
information which might identify you will be gathered after that date.  Information that has 
already been gathered may still be used and given to others. This would be done if it were 
necessary for the research to be reliable.
Collection of Identifiable Private Information or Identifiable Biospecimens: 

Identifiers might be removed from your identifiable private information. After such removal, 
the information could be used for future research studies or distributed to another 
investigator for future research studies without your additional informed consent (or consent 
from your legally authorized representative).
Notice Concerning HIV-Related Information: HIV-related information that either is collected as 
part of the research or that may already exist in your medical record might be accessed for the 
research by the research staff and the study sponsor, but will not be shared with others without 
your authorization, unless federal or state law requires the disclosure. You have a right to 
request a list of people who may receive or use your HIV-related information without 
authorization. If you experience discrimination because of the release or disclosure of HIV-
related information, you may contact the New York State Division of Human Rights or the New 
York City Commission on Human Rights. These agencies are responsible for protecting your 
rights.
CoC (CERTIFICATE OF CONFIDENTIALITY)
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. 
The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
 
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consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects.
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by Weill Cornell Medicine which is funding this project or for information that 
must be disclosed in order to meet the requirements of the federal Food and Drug 
Administration (FDA). You should understand that a Certificate of Confidentiality does not 
prevent you from voluntarily releasing information about yourself or your involvement in this 
research. If you want your research information released to an insurer, medical care provider, or 
any other person not connected with the research, you must provide consent to allow the 
researchers to release it.
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law. Some examples are laws that require reporting of child or elder abuse, some 
communicable diseases, and threats to harm yourself or others.
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have 
consented to in this informed consent document such as research data in your medical record.
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is voluntary.  You may decide not to participate or you may stop 
your participation at any time, without penalty or loss of benefits or medical care to which you 
are otherwise entitled. If you decide to leave the study, please tell the study doctor as soon as 
possible.  
If you choose to withdraw from the study early, it is important to know that data collected up until 
the time you withdraw will remain part of the study database and cannot be removed, and will 
still be used and given to others.
Your participation in this study may be stopped without your consent at any time and for any 
reason by the study doctor, the sponsor, the FDA or other regulatory authorities. Reasons you 
may be withdrawn from the study include it is determined to be in your best interest, you need 
treatment not allowed in this study, you do not follow the study instructions, the study is 
stopped, or for other administrative reasons.  If you leave the study early, you may be asked to 
return to the study doctor’s office for a final study visit for your safety.
 
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CONTACT FOR ADDITIONAL RESEARCH 
Please indicate whether you will allow the investigator to provide your contact info to members 
of the research team at Memorial Sloan Kettering (MSK) to tell you about an opportunity 
for additional research. Please check the box below that describes your wishes:
  YES, the investigator may provide my contact information to members of the 
research team at MSK. 
  NO, the investigator may not provide my contact information to MSK. 
CONTACTS FOR QUESTIONS, COMPLAINTS, CONCERNS
If you have any questions or requests for information relating to this research study or your 
participation in it, or if you want to voice a complaint or concern about this research, or if you 
have a study related injury, you may contact Dr. Jim C. Hu at (646) 962-9600.  
If you have any questions about your rights as a research subject or complaints regarding this 
research study, or you are unable to reach the research staff, you may contact a person 
independent of the research team at the Biomedical Research Alliance of New York Institutional 
Review Board at 516-318-6877. Questions, concerns or complaints about research can also be 
registered with the Biomedical Research Alliance of New York Institutional Review Board at 
www.branyirb.com/concerns-about-research.
STATEMENT OF CONSENT 
By signing this form, I confirm the following:

I have read all of this consent form and know what is involved in the study. 

All of my questions have been answered to my satisfaction. 

I can leave the study at any time without giving a reason and without penalty.

I agree to the collection, use, sharing and analysis of my personal health information and 
study information collected as part of this study by the sponsor and other authorized 
persons and regulatory agencies as described in this form. 

I will be given a copy of this signed consent form to keep. 

I do not give up any legal rights by signing this form. 
I voluntarily agree to participate in this study.
___________________________________________________________________________
Subject: Name (Print)
Signature
Date
___________________________________________________________________________
Person Obtaining Consent: Name (Print)
Signature
Date
 
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