Prostate CancerTRAP-PAINNCT07577895
Pain Comparison: Transrectal vs. Transperineal Prostate Biopsy
An observational study of Prostate Cancer, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Prostate biopsy remains the gold standard for the diagnosis of prostate cancer and is most commonly performed using either the transrectal or transperineal approach. Although both techniques offer acceptable diagnostic accuracy, the pain experienced during and after the procedure is an important factor influencing the… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2026to 10 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of male patients with a clinical indication for prostate biopsy, including elevated serum prostate-specific antigen (PSA) levels, abnormal findings on digital rectal examination (DRE), and/or suspicious lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI). Patients will be recruited consecutively from the urology outpatient clinic and will undergo prostate biopsy via either the transrectal or transperineal approach. Only patients undergoing prostate biopsy for the first time, who are able to understand and complete the Visual Analog Scale (VAS) for pain assessment, and who provide written informed consent will be included.
Who may be able to join
- Male patients aged 18 years and older Patients with clinical indication for prostate biopsy (elevated serum prostate-specific antigen [PSA] level, abnormal digital rectal examination [DRE], and/or suspicious lesion on multiparametric prostate magnetic resonance imaging [mpMRI])
- Patients undergoing prostate biopsy for the first time
- Patients able to understand and complete the Visual Analog Scale (VAS) for pain assessment
- Patients who have provided written informed consent to participate in the study
Who cannot join
- Patients with a history of previous prostate biopsy
- Patients with a previously confirmed diagnosis of prostate cancer
- Patients with active urinary tract infection or prostatitis at the time of biopsy
- Patients with anorectal pathology that may interfere with the transrectal approach (e.g., anal stenosis, active hemorrhoidal disease, anal fissure, prior rectal surgery)
- Patients with perineal pathology that may interfere with the transperineal approach (e.g., perineal infection, scarring, or prior surgery)
- Patients with bleeding diathesis or those receiving anticoagulant therapy that cannot be safely discontinued before the procedure
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- Patients with known allergy or hypersensitivity to local anesthetic agents
- Patients with chronic pain syndromes or those receiving regular analgesic or opioid treatment that may affect pain perception
- Patients with cognitive impairment, psychiatric disorders, or language barriers preventing reliable use of the Visual Analog Scale (VAS)
- Patients who refuse to participate or do not provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kayseri Education and Research Hospital
Kayseri, Kocasinan, 38080
Abdullah Gölbaşı, Assistant Professor, +90554 281 4955, dr.abdullahgolbasi@gmail.com
Abdullah Gölbaşı, Assistant Professor
About this study
Official title: Comparison of Anticipated and Experienced Pain Levels in Transrectal Versus Transperineal Prostate Biopsy
Prostate biopsy remains the gold standard for the diagnosis of prostate cancer and is most commonly performed using either the transrectal or transperineal approach. Although both techniques offer acceptable diagnostic accuracy, the pain experienced during and after the procedure is an important factor influencing the choice of biopsy approach and overall patient comfort. Pain perception in prostate biopsy is multifactorial, depending on the biopsy route, the number of needle insertions, the local anesthesia protocol, and the innervation of the relevant anatomical structures. The aim of this prospective study is to compare anticipated (pre-procedural expected) and experienced (post-procedural actual) pain levels in patients undergoing transrectal versus transperineal prostate biopsy, using the Visual Analog Scale (VAS). Findings are expected to contribute to clinical decision-making regarding biopsy approach selection with a focus on patient comfort.
Read the detailed description
Prostate biopsy is currently the gold standard diagnostic procedure for prostate cancer and is widely performed worldwide. In contemporary clinical practice, prostate biopsy is most frequently carried out using either the transrectal or the transperineal approach. While the diagnostic efficacy of both methods is considered acceptable, the pain perceived by patients during and after the procedure is a significant factor that influences the selection of the biopsy approach.
Pain perception during prostate biopsy is influenced by multiple variables, including the biopsy route, the number of needle insertions, the local anesthesia technique applied, and the innervation of the anatomical structures involved. In transrectal biopsy, the rectal wall is traversed, whereas in transperineal biopsy, the perineal skin and deeper tissues are penetrated; therefore, pain arises through different mechanisms in each technique. For this reason, comparing pain levels between the two biopsy approaches is of clinical importance for improving patient comfort.
The use of standardized assessment tools such as the Visual Analog Scale (VAS) allows the subjective pain experience of patients to be quantified and compared objectively. Previous studies utilizing VAS in prostate biopsy have reported differences in pain scores depending on the biopsy approach.
Although several studies have compared transrectal and transperineal biopsy approaches in terms of pain levels, the available evidence is heterogeneous due to differences in patient populations, anesthesia protocols, and timing of pain assessment. Furthermore, biopsy practices and patient expectations may vary across geographical regions, which can also influence pain perception. Therefore, prospective data obtained from our own patient population are expected to contribute to clinical decision-making processes regarding the selection of the biopsy approach with a particular focus on patient comfort.
Study Procedures Prior to the procedure, all patients scheduled to undergo prostate biopsy will receive detailed verbal and written information regarding both the transrectal and transperineal biopsy techniques, including their respective procedural steps, potential advantages, and possible disadvantages. Specifically, the advantages of transrectal biopsy (such as ease of application and shorter procedural time) and its potential disadvantages (such as the risk of infection) will be explained. Likewise, the advantages of transperineal biopsy (including a lower risk of infection and the ability to sample different anatomical regions), as well as its potential drawbacks (such as pain associated with perineal access and a longer procedural time), will be described.
Following this informational session, written informed consent will be obtained from all patients willing to participate in the study.
Anesthesia Protocol In order to standardize the anesthesia protocol and minimize its effect as a confounding variable on pain perception, periprostatic nerve block will be performed in both study arms. The same local anesthetic technique will be applied to all patients regardless of the biopsy approach (transrectal or transperineal), ensuring that any observed difference in pain scores between groups can be attributed to the biopsy route rather than to differences in anesthesia.
Outcome Assessment The sole focus of this study is the assessment of pain perception associated with the biopsy procedure; no other clinical endpoints (such as infection rates, bleeding complications, or diagnostic yield) will be evaluated within the scope of this study.
Anticipated pain levels will be assessed using the Visual Analog Scale (VAS) prior to the procedure, after the patient has been informed about both biopsy techniques. Experienced pain levels will be evaluated using the same scale as a single measurement immediately after the completion of the biopsy procedure. The primary objective of the study is to compare anticipated and experienced pain scores between patients undergoing transrectal and transperineal prostate biopsy.
- Conditions
- Prostate Cancer
- Keywords
- prostat cancer, pain, outpatient urology, pain perception, prostate biopsy
- Medical subject headings
- Prostatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal Prostate Biopsy Group | Patients in this group will undergo prostate biopsy via the transrectal approach. Prior to the procedure, periprostatic nerve block will be performed as the standard local anesthesia protocol. The biopsy needle will be introduced through the rectal wall under transrectal ultrasound (TRUS) guidance to obtain prostate tissue samples. Anticipated pain will be assessed using the Visual Analog Scale (VAS) before the procedure, after the patient has been informed about both biopsy techniques. Experienced pain will be assessed with the VAS as a single measurement immediately after completion of the biopsy. | |
| Transperineal Prostate Biopsy Group | Patients in this group will undergo prostate biopsy via the transperineal approach. Prior to the procedure, periprostatic nerve block will be performed as the standard local anesthesia protocol. The biopsy needle will be introduced through the perineal skin under transrectal ultrasound (TRUS) guidance to obtain prostate tissue samples. Anticipated pain will be assessed using the Visual Analog Scale (VAS) before the procedure, after the patient has been informed about both biopsy techniques. Experienced pain will be assessed with the VAS as a single measurement immediately after completion of the biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Experienced Pain Scores Between Transrectal and Transperineal Prostate Biopsy Groups
Experienced pain (perceived immediately after the procedure) will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable). Post-procedural VAS scores will be compared between the transrectal and transperineal prostate biopsy groups.
Measured: Within 15 minutes after completion of the biopsy procedure
Secondary outcomes (3)
Pre-Procedural Anticipated Pain Level
Anticipated pain level assessed immediately before the procedure using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable).
Measured: Within 30 minutes before the biopsy procedure
Post-Procedural Experienced Pain Level
Experienced pain level assessed immediately after the procedure using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable).
Measured: From immediately before to immediately after prostate biopsy
Effect of Age on Pain Perception
Association between patient age and post-procedural experienced pain intensity during prostate biopsy.
Measured: Immediately after prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start10 May 2026 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Gölbaşi, Kayseri Education and Research Hospital
- Investigators
- Mert Ali Karadağ, Professor, Study chair, Kayseri Education and Research HospitalAbdullah Gölbaşı, Assistant Professor, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577895
- Sponsor's protocol ID
- SBU-URO-AG-04
- Acronym
- TRAP-PAIN
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anticipated and Experienced Pain Levels in Transrectal Versus Transperineal Prostate Biopsy
- ClinicalTrials.gov ID
- NCT07577895
- Acronym / sponsor ID
- TRAP-PAIN / SBU-URO-AG-04
- Conditions
- Prostate Cancer
- Keywords
- prostat cancer, pain, outpatient urology, pain perception, prostate biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 11 May 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.
Prostate biopsy remains the gold standard for the diagnosis of prostate cancer and is most commonly performed using either the transrectal or transperineal approach. Although both techniques offer acceptable diagnostic accuracy, the pain experienced during and after the procedure is an important factor influencing the choice of biopsy approach and overall patient comfort. Pain perception in prostate biopsy is multifactorial, depending on the biopsy route, the number of needle insertions, the local anesthesia protocol, and the innervation of the relevant anatomical structures. The aim of this prospective study is to compare anticipated (pre-procedural expected) and experienced (post-procedural actual) pain levels in patients undergoing transrectal versus transperineal prostate biopsy, using the Visual Analog Scale (VAS). Findings are expected to contribute to clinical decision-making regarding biopsy approach selection with a focus on patient comfort.
Detailed description
Prostate biopsy is currently the gold standard diagnostic procedure for prostate cancer and is widely performed worldwide. In contemporary clinical practice, prostate biopsy is most frequently carried out using either the transrectal or the transperineal approach. While the diagnostic efficacy of both methods is considered acceptable, the pain perceived by patients during and after the procedure is a significant factor that influences the selection of the biopsy approach.
Pain perception during prostate biopsy is influenced by multiple variables, including the biopsy route, the number of needle insertions, the local anesthesia technique applied, and the innervation of the anatomical structures involved. In transrectal biopsy, the rectal wall is traversed, whereas in transperineal biopsy, the perineal skin and deeper tissues are penetrated; therefore, pain arises through different mechanisms in each technique. For this reason, comparing pain levels between the two biopsy approaches is of clinical importance for improving patient comfort.
The use of standardized assessment tools such as the Visual Analog Scale (VAS) allows the subjective pain experience of patients to be quantified and compared objectively. Previous studies utilizing VAS in prostate biopsy have reported differences in pain scores depending on the biopsy approach.
Although several studies have compared transrectal and transperineal biopsy approaches in terms of pain levels, the available evidence is heterogeneous due to differences in patient populations, anesthesia protocols, and timing of pain assessment. Furthermore, biopsy practices and patient expectations may vary across geographical regions, which can also influence pain perception. Therefore, prospective data obtained from our own patient population are expected to contribute to clinical decision-making processes regarding the selection of the biopsy approach with a particular focus on patient comfort.
Study Procedures Prior to the procedure, all patients scheduled to undergo prostate biopsy will receive detailed verbal and written information regarding both the transrectal and transperineal biopsy techniques, including their respective procedural steps, potential advantages, and possible disadvantages. Specifically, the advantages of transrectal biopsy (such as ease of application and shorter procedural time) and its potential disadvantages (such as the risk of infection) will be explained. Likewise, the advantages of transperineal biopsy (including a lower risk of infection and the ability to sample different anatomical regions), as well as its potential drawbacks (such as pain associated with perineal access and a longer procedural time), will be described.
Following this informational session, written informed consent will be obtained from all patients willing to participate in the study.
Anesthesia Protocol In order to standardize the anesthesia protocol and minimize its effect as a confounding variable on pain perception, periprostatic nerve block will be performed in both study arms. The same local anesthetic technique will be applied to all patients regardless of the biopsy approach (transrectal or transperineal), ensuring that any observed difference in pain scores between groups can be attributed to the biopsy route rather than to differences in anesthesia.
Outcome Assessment The sole focus of this study is the assessment of pain perception associated with the biopsy procedure; no other clinical endpoints (such as infection rates, bleeding complications, or diagnostic yield) will be evaluated within the scope of this study.
Anticipated pain levels will be assessed using the Visual Analog Scale (VAS) prior to the procedure, after the patient has been informed about both biopsy techniques. Experienced pain levels will be evaluated using the same scale as a single measurement immediately after the completion of the biopsy procedure. The primary objective of the study is to compare anticipated and experienced pain scores between patients undergoing transrectal and transperineal prostate biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transrectal Prostate Biopsy Group | – | –Patients in this group will undergo prostate biopsy via the transrectal approach. Prior to the procedure, periprostatic nerve block will be performed as the standard local anesthesia protocol. The biopsy needle will be introduced through the rectal wall under transrectal ultrasound (TRUS) guidance to obtain prostate tissue samples. Anticipated pain will be assessed using the Visual Analog Scale (VAS) before the procedure, after the patient has been informed about both biopsy techniques. Experienced pain will be assessed with the VAS as a single measurement immediately after completion of the biopsy. |
| Transperineal Prostate Biopsy Group | – | –Patients in this group will undergo prostate biopsy via the transperineal approach. Prior to the procedure, periprostatic nerve block will be performed as the standard local anesthesia protocol. The biopsy needle will be introduced through the perineal skin under transrectal ultrasound (TRUS) guidance to obtain prostate tissue samples. Anticipated pain will be assessed using the Visual Analog Scale (VAS) before the procedure, after the patient has been informed about both biopsy techniques. Experienced pain will be assessed with the VAS as a single measurement immediately after completion of the biopsy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of male patients with a clinical indication for prostate biopsy, including elevated serum prostate-specific antigen (PSA) levels, abnormal findings on digital rectal examination (DRE), and/or suspicious lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI). Patients will be recruited consecutively from the urology outpatient clinic and will undergo prostate biopsy via either the transrectal or transperineal approach. Only patients undergoing prostate biopsy for the first time, who are able to understand and complete the Visual Analog Scale (VAS) for pain assessment, and who provide written informed consent will be included.
Key inclusion criteria (4 listed)
- Male patients aged 18 years and older Patients with clinical indication for prostate biopsy (elevated serum prostate-specific antigen [PSA] level, abnormal digital rectal examination [DRE], and/or suspicious lesion on multiparametric prostate magnetic resonance imaging [mpMRI])
- Patients undergoing prostate biopsy for the first time
- Patients able to understand and complete the Visual Analog Scale (VAS) for pain assessment
- Patients who have provided written informed consent to participate in the study
Key exclusion criteria (10 listed)
- Patients with a history of previous prostate biopsy
- Patients with a previously confirmed diagnosis of prostate cancer
- Patients with active urinary tract infection or prostatitis at the time of biopsy
- Patients with anorectal pathology that may interfere with the transrectal approach (e.g., anal stenosis, active hemorrhoidal disease, anal fissure, prior rectal surgery)
- Patients with perineal pathology that may interfere with the transperineal approach (e.g., perineal infection, scarring, or prior surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Experienced Pain Scores Between Transrectal and Transperineal Prostate Biopsy Groups
Time frame: Within 15 minutes after completion of the biopsy procedure
Experienced pain (perceived immediately after the procedure) will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable). Post-procedural VAS scores will be compared between the transrectal and transperineal prostate biopsy groups.
3 secondary outcomes
Pre-Procedural Anticipated Pain Level
Time frame: Within 30 minutes before the biopsy procedure
Post-Procedural Experienced Pain Level
Time frame: From immediately before to immediately after prostate biopsy
Effect of Age on Pain Perception
Time frame: Immediately after prostate 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 11 May 2026.
- Individual participant dataSharing planned: No
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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.
Mert Ali Karadağ, Professor study chair
Kayseri Education and Research Hospital
Abdullah Gölbaşı, Assistant Professor principal investigator
Kayseri Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
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 10 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: opening soon, as of the sponsor's last update on 11 May 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 Turkey (Türkiye). 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?
Contact Abdullah Gölbaşı, Assistant Professor (+90 352 315 77 00, kayserisehir@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Experienced Pain Scores Between Transrectal and Transperineal Prostate Biopsy Groups (time frame: Within 15 minutes after completion of the biopsy procedure). 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 11 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.