Prostate BiopsyRPCABNCT07550985
Routine Probe Compression After Transrectal Prostate Biopsy(RPCAB) to Reduce Bleeding and Infectious Complications
A study testing Probe compression in people with Prostate Biopsy and Post Biopsy Bleeding, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Hematuria (up to 50%) and rectal bleeding (up to 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are mild, some require additional intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Biopsy, Post Biopsy Bleeding, Transrectal Ultrasound-guided Prostate Biopsy
- What is being tested?
- Probe compression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged ≥18 years
- Scheduled to undergo transrectal ultrasound-guided prostate biopsy
- Biopsy-naïve patients (first-time prostate biopsy)
- Able to provide written informed consent
Who cannot join
- Uncorrectable coagulopathy or bleeding disorder
- Active urinary tract infection at the time of biopsy
- Acute anorectal conditions (e.g., hemorrhoidal bleeding, anal fissure, proctitis)
- Inability to discontinue or appropriately manage anticoagulant or antiplatelet therapy
- History of severe drug allergy or hypersensitivity to medications used in the study
- Individuals unable to provide informed consent (e.g., cognitive impairment, medically incapacitated) or other vulnerable populations
Show all 9Show fewer
- Participation in another interventional study related to prostate disease that may interfere with the outcomes of this study
- Severe comorbid conditions limiting study participation
- Inability to comply with follow-up procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
VHS medical center
Seoul, Seoul, 05368
Jaehyun Ryu, MD, +82-10-5234-1222, ryujaehyun1@gmail.com
Jaehyun Ryu, MD
About this study
Official title: A Randomized Controlled Trial Evaluating the Effect of Routine Probe Compression After Transrectal Prostate Biopsy on Bleeding and Infectious Complications
Hematuria (up to 50%) and rectal bleeding (up to 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are mild, some require additional intervention. Short-duration compression has been shown to achieve hemostasis in cases of post-biopsy bleeding, suggesting that routine probe compression may reduce bleeding complications. Post-biopsy bleeding may also be associated with an increased risk of subsequent infection.
This randomized controlled trial aims to evaluate the effect of routine probe compression and compression duration after transrectal prostate biopsy on bleeding and infectious complications.
Read the detailed description
Hematuria (approximately 50%) and rectal bleeding (approximately 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are self-limited, a subset of patients require additional intervention. In cases of significant bleeding immediately after biopsy, ultrasound-guided probe compression has been used for hemostasis, with reported compression times ranging from 1 to 8 minutes (mean 2.9 minutes), suggesting that even short-duration compression may be effective.
Digital rectal compression for 5 minutes after biopsy has been shown to reduce intraprostatic hemorrhage (hematoma), thereby improving the accuracy of subsequent magnetic resonance imaging interpretation. However, no randomized controlled trials have evaluated clinically significant bleeding outcomes, such as hematuria or rectal bleeding, as primary endpoints.
While a stepwise approach to managing moderate-to-severe rectal bleeding (initial direct compression followed by endoscopic hemostasis or embolization if needed) is generally accepted, there is no consensus regarding the optimal duration of initial compression.
Infectious complications following transrectal prostate biopsy occur in approximately 0.1-7.0% of patients, with sepsis reported in 0.3-3.1%. Post-biopsy hematuria has been suggested as a potential clinical indicator of subsequent urinary tract infection. Therefore, reducing bleeding complications may also contribute to the prevention of infectious complications.
There is a clear need for randomized evidence evaluating the effect of routine probe compression and compression duration on both bleeding and infectious outcomes. This study aims to address this gap in the current evidence.
Study Procedures
Participants will be randomly assigned in a 1:1:1 ratio immediately after transrectal ultrasound-guided prostate biopsy using a computer-generated randomization schedule to one of three groups based on probe compression duration: 0 minutes (no compression), 1 minute, or 3 minutes.
Probe compression will be performed by a designated study investigator immediately after biopsy. Blinding will be maintained as much as feasible: the operator, participants, and outcome assessors will be blinded to group allocation whenever possible.
All participants will receive standard prophylactic measures according to institutional practice, including a single dose of intravenous ceftriaxone (2 g) followed by oral levofloxacin (500 mg) for 3 days, as well as rectal disinfection prior to biopsy.
Follow-up will include a structured telephone interview within 7 days after biopsy to assess post-procedural symptoms (approximately 3 minutes in duration). In addition, participants will undergo an outpatient clinic visit between 7 and 14 days after biopsy, during which routine laboratory tests, including complete blood count (CBC), C-reactive protein (CRP), and urinalysis, will be performed.
The study intervention may increase the total procedure time by up to 3 minutes, depending on the assigned compression duration (0, 1, or 3 minutes).
- Being tested
- Probe compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe compressionBehavioural
Probe compression using the transrectal ultrasound probe applied immediately after biopsy, with duration of 0, 1, or 3 minutes according to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Probe compression (0 minutes) | No intervention | No probe compression is applied after completion of transrectal ultrasound-guided prostate biopsy. |
| Probe compression (1 minute) | Active comparator | The transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 1 minute immediately after biopsy. Receives: Behavioral: Probe compression |
| Probe compression (3 minutes) | Active comparator | The transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 3 minutes immediately after biopsy. Receives: Behavioral: Probe compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant bleeding after transrectal prostate biopsy
Proportion of patients reporting hematuria or rectal bleeding within 7 days after biopsy, assessed by structured telephone interview. Clinically significant bleeding is defined as bleeding associated with patient-reported symptoms, prolonged duration, or requiring medical attention.
Measured: Within 7 days after biopsy
Secondary outcomes (1)
Incidence of infectious complications
Occurrence of fever, urinary tract infection, or sepsis based on patient-reported symptoms and laboratory findings.
Measured: Within 14 days after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start30 Mar 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550985
- Sponsor's protocol ID
- BOHUN-2026-01-044-002
- Acronym
- RPCAB
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effect of Routine Probe Compression After Transrectal Prostate Biopsy on Bleeding and Infectious Complications
- ClinicalTrials.gov ID
- NCT07550985
- Acronym / sponsor ID
- RPCAB / BOHUN-2026-01-044-002
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, KoreaUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hematuria (up to 50%) and rectal bleeding (up to 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are mild, some require additional intervention. Short-duration compression has been shown to achieve hemostasis in cases of post-biopsy bleeding, suggesting that routine probe compression may reduce bleeding complications. Post-biopsy bleeding may also be associated with an increased risk of subsequent infection.
This randomized controlled trial aims to evaluate the effect of routine probe compression and compression duration after transrectal prostate biopsy on bleeding and infectious complications.
Detailed description
Hematuria (approximately 50%) and rectal bleeding (approximately 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are self-limited, a subset of patients require additional intervention. In cases of significant bleeding immediately after biopsy, ultrasound-guided probe compression has been used for hemostasis, with reported compression times ranging from 1 to 8 minutes (mean 2.9 minutes), suggesting that even short-duration compression may be effective.
Digital rectal compression for 5 minutes after biopsy has been shown to reduce intraprostatic hemorrhage (hematoma), thereby improving the accuracy of subsequent magnetic resonance imaging interpretation. However, no randomized controlled trials have evaluated clinically significant bleeding outcomes, such as hematuria or rectal bleeding, as primary endpoints.
While a stepwise approach to managing moderate-to-severe rectal bleeding (initial direct compression followed by endoscopic hemostasis or embolization if needed) is generally accepted, there is no consensus regarding the optimal duration of initial compression.
Infectious complications following transrectal prostate biopsy occur in approximately 0.1-7.0% of patients, with sepsis reported in 0.3-3.1%. Post-biopsy hematuria has been suggested as a potential clinical indicator of subsequent urinary tract infection. Therefore, reducing bleeding complications may also contribute to the prevention of infectious complications.
There is a clear need for randomized evidence evaluating the effect of routine probe compression and compression duration on both bleeding and infectious outcomes. This study aims to address this gap in the current evidence.
Study Procedures
Participants will be randomly assigned in a 1:1:1 ratio immediately after transrectal ultrasound-guided prostate biopsy using a computer-generated randomization schedule to one of three groups based on probe compression duration: 0 minutes (no compression), 1 minute, or 3 minutes.
Probe compression will be performed by a designated study investigator immediately after biopsy. Blinding will be maintained as much as feasible: the operator, participants, and outcome assessors will be blinded to group allocation whenever possible.
All participants will receive standard prophylactic measures according to institutional practice, including a single dose of intravenous ceftriaxone (2 g) followed by oral levofloxacin (500 mg) for 3 days, as well as rectal disinfection prior to biopsy.
Follow-up will include a structured telephone interview within 7 days after biopsy to assess post-procedural symptoms (approximately 3 minutes in duration). In addition, participants will undergo an outpatient clinic visit between 7 and 14 days after biopsy, during which routine laboratory tests, including complete blood count (CBC), C-reactive protein (CRP), and urinalysis, will be performed.
The study intervention may increase the total procedure time by up to 3 minutes, depending on the assigned compression duration (0, 1, or 3 minutes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probe compression (0 minutes) | No intervention | –No probe compression is applied after completion of transrectal ultrasound-guided prostate biopsy. |
| Probe compression (1 minute) | Active comparator | Behavioral: Probe compressionThe transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 1 minute immediately after biopsy. |
| Probe compression (3 minutes) | Active comparator | Behavioral: Probe compressionThe transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 3 minutes immediately after biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged ≥18 years
- Scheduled to undergo transrectal ultrasound-guided prostate biopsy
- Biopsy-naïve patients (first-time prostate biopsy)
- Able to provide written informed consent
Key exclusion criteria (9 listed)
- Uncorrectable coagulopathy or bleeding disorder
- Active urinary tract infection at the time of biopsy
- Acute anorectal conditions (e.g., hemorrhoidal bleeding, anal fissure, proctitis)
- Inability to discontinue or appropriately manage anticoagulant or antiplatelet therapy
- History of severe drug allergy or hypersensitivity to medications used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probe compressionProbe compression using the transrectal ultrasound probe applied immediately after biopsy, with duration of 0, 1, or 3 minutes according to randomization. | Behavioural | Probe compression (1 minute), Probe compression (3 minutes) |
Primary outcome
Incidence of clinically significant bleeding after transrectal prostate biopsy
Time frame: Within 7 days after biopsy
Proportion of patients reporting hematuria or rectal bleeding within 7 days after biopsy, assessed by structured telephone interview. Clinically significant bleeding is defined as bleeding associated with patient-reported symptoms, prolonged duration, or requiring medical attention.
1 secondary outcome
Incidence of infectious complications
Time frame: Within 14 days after biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probe compression in people with Prostate Biopsy and Post Biopsy Bleeding, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically significant bleeding after transrectal prostate biopsy (time frame: Within 7 days after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.