Prostate Cancer (Diagnosis)PRO-PAINNCT07683182
Intraprostatic Anesthesia During Transperineal Prostate Biopsy
A study testing Prilocaine, Bupivacaine and Perineal Local Anesthesia in people with Prostate Cancer (Diagnosis) and Prostate-Specific Antigen, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), Prostate-Specific Antigen
- What is being tested?
- Prilocaine, Bupivacaine and Perineal Local Anesthesia
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Sep 2026
- 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 or older
- Clinical indication for transperineal prostate biopsy based on elevated prostate-specific antigen (PSA) level and/or suspicious digital rectal examination findings
- Ability to understand and complete the Hospital Anxiety and Depression Scale (HADS)
- Ability to provide pain scores using a 10-point Visual Analog Scale (VAS)
- Provision of written informed consent
Who cannot join
- Previous history of prostate biopsy
- Known hypersensitivity or contraindication to local anesthetic agents
- Hematological disorders affecting coagulation
- Active urinary tract infection
- Neurological disorders that may affect pain perception
- Psychiatric disorders that may affect pain assessment or completion of study -questionnaires
- Inability to complete the HADS questionnaire or VAS assessment
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul, Pendik, 34722
About this study
Official title: The Effect of Intraprostatic Local Anesthesia on Pain Perception During Transperineal Prostate Biopsy Under Local Anesthesia
Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to undergo repeat biopsy when necessary.
This prospective randomized controlled study aims to evaluate whether the addition of intraprostatic local anesthesia to standard perineal local anesthesia reduces pain during transperineal prostate biopsy. Fifty patients undergoing prostate biopsy under local anesthesia will be randomized into two groups. The first group will receive standard perineal local anesthesia, while the second group will receive additional intraprostatic local anesthesia.
Read more
Pain severity will be assessed before, during, and after the procedure using a visual analog scale (VAS). Anxiety and depression levels will be evaluated preoperatively using the Hospital Anxiety and Depression Scale (HADS). Patient-related factors, procedural characteristics, and post-procedural outcomes will also be recorded to identify factors associated with pain perception.
The results of this study may help optimize local anesthesia techniques and improve patient comfort during transperineal prostate biopsy.
Read the detailed description
Transperineal prostate biopsy is currently considered the preferred approach for prostate cancer diagnosis because of its low risk of infectious complications and favorable safety profile. Despite these advantages, pain experienced during the procedure remains a significant concern and may adversely affect patient satisfaction, procedural tolerance, and acceptance of repeat biopsy when clinically indicated.
Pain during prostate biopsy is primarily related to the rich autonomic innervation of the prostatic capsule and stroma. Perineal local anesthesia is commonly used to reduce procedural discomfort; however, pain may still occur, particularly during needle sampling of the prostatic parenchyma. Intraprostatic local anesthetic infiltration has been proposed as an adjunctive technique to provide more comprehensive analgesia by directly targeting the biopsy area. Previous studies have suggested that the addition of intraprostatic anesthesia may further reduce pain during prostate biopsy procedures.
The objective of this prospective randomized controlled study is to investigate the impact of intraprostatic local anesthesia on pain perception during transperineal prostate biopsy performed under local anesthesia. In addition, the study aims to evaluate the association between procedural pain and patient-related factors, including anxiety and depression levels assessed by the Hospital Anxiety and Depression Scale (HADS), as well as clinical and procedural characteristics.
The findings of this study may contribute to the optimization of local anesthesia protocols and improve patient comfort during transperineal prostate biopsy.
- Being tested
- Prilocaine, Bupivacaine, Perineal Local Anesthesia, Intraprostatic Local Anesthesia, Transperineal Prostate Biopsy
- Keywords
- Transperineal Prostate Biopsy, Intraprostatic Anesthesia, Local Anesthesia, Pain Assessment
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrilocaineDrug
Prilocaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group.
BupivacaineDrug
Bupivacaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group.
Perineal Local AnesthesiaProcedure or surgery
Participants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy.
Intraprostatic Local AnesthesiaProcedure or surgery
Participants receive intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes during transperineal prostate biopsy.
Transperineal Prostate BiopsyProcedure or surgery
Participants undergo standard transperineal prostate biopsy under local anesthesia according to the institutional biopsy protocol.
Transrectal Ultrasound (TRUS) SystemDevice
A transrectal ultrasound (TRUS) system is used to provide real-time ultrasound guidance during transperineal prostate biopsy. The TRUS probe is inserted into the rectum to visualize the prostate and guide accurate needle placement through the perineum for systematic prostate biopsy under local anesthesia. The device is used in both study groups.
| Study group | Role | What they receive |
|---|---|---|
| Perineal Local Anesthesia | Active comparator | Participants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy. Receives: Drug: Prilocaine; Drug: Bupivacaine; Procedure: Perineal Local Anesthesia; Procedure: Transperineal Prostate Biopsy; Device: Transrectal Ultrasound (TRUS) System |
| Perineal Plus Intraprostatic Local Anesthesia | Experimental | Participants receive standard perineal local anesthesia plus intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes before transperineal prostate biopsy. Receives: Drug: Prilocaine; Drug: Bupivacaine; Procedure: Perineal Local Anesthesia; Procedure: Intraprostatic Local Anesthesia; Procedure: Transperineal Prostate Biopsy; Device: Transrectal Ultrasound (TRUS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Transperineal Prostate Biopsy
Pain severity during transperineal prostate biopsy will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity. Pain scores will be compared between participants receiving perineal local anesthesia alone and those receiving additional intraprostatic local anesthesia.
Measured: During the biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either standard perineal local anesthesia alone or perineal local anesthesia combined with intraprostatic local anesthesia during transperineal prostate biopsy. Pain scores before, during, and after the procedure will be compared between the two parallel study groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683182
- Sponsor's protocol ID
- MAR.UAD.0033
- Acronym
- PRO-PAIN
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared in order to protect participant confidentiality and comply with ethical and institutional requirements. De-identified data may be made available upon reasonable request for scientifically and medically justified purposes, subject to review and approval by the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraprostatic Local Anesthesia on Pain Perception During Transperineal Prostate Biopsy Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT07683182
- Acronym / sponsor ID
- PRO-PAIN / MAR.UAD.0033
- Keywords
- Transperineal Prostate Biopsy, Intraprostatic Anesthesia, Local Anesthesia, Pain Assessment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Jul 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.
Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to undergo repeat biopsy when necessary.
This prospective randomized controlled study aims to evaluate whether the addition of intraprostatic local anesthesia to standard perineal local anesthesia reduces pain during transperineal prostate biopsy. Fifty patients undergoing prostate biopsy under local anesthesia will be randomized into two groups. The first group will receive standard perineal local anesthesia, while the second group will receive additional intraprostatic local anesthesia.
Pain severity will be assessed before, during, and after the procedure using a visual analog scale (VAS). Anxiety and depression levels will be evaluated preoperatively using the Hospital Anxiety and Depression Scale (HADS). Patient-related factors, procedural characteristics, and post-procedural outcomes will also be recorded to identify factors associated with pain perception.
The results of this study may help optimize local anesthesia techniques and improve patient comfort during transperineal prostate biopsy.
Detailed description
Transperineal prostate biopsy is currently considered the preferred approach for prostate cancer diagnosis because of its low risk of infectious complications and favorable safety profile. Despite these advantages, pain experienced during the procedure remains a significant concern and may adversely affect patient satisfaction, procedural tolerance, and acceptance of repeat biopsy when clinically indicated.
Pain during prostate biopsy is primarily related to the rich autonomic innervation of the prostatic capsule and stroma. Perineal local anesthesia is commonly used to reduce procedural discomfort; however, pain may still occur, particularly during needle sampling of the prostatic parenchyma. Intraprostatic local anesthetic infiltration has been proposed as an adjunctive technique to provide more comprehensive analgesia by directly targeting the biopsy area. Previous studies have suggested that the addition of intraprostatic anesthesia may further reduce pain during prostate biopsy procedures.
The objective of this prospective randomized controlled study is to investigate the impact of intraprostatic local anesthesia on pain perception during transperineal prostate biopsy performed under local anesthesia. In addition, the study aims to evaluate the association between procedural pain and patient-related factors, including anxiety and depression levels assessed by the Hospital Anxiety and Depression Scale (HADS), as well as clinical and procedural characteristics.
The findings of this study may contribute to the optimization of local anesthesia protocols and improve patient comfort during transperineal prostate biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either standard perineal local anesthesia alone or perineal local anesthesia combined with intraprostatic local anesthesia during transperineal prostate biopsy. Pain scores before, during, and after the procedure will be compared between the two parallel study groups.
| Arm | Type | Receives |
|---|---|---|
| Perineal Local Anesthesia | Active comparator | Drug: Prilocaine, Drug: Bupivacaine, Procedure: Perineal Local Anesthesia, Procedure: Transperineal Prostate Biopsy, Device: Transrectal Ultrasound (TRUS) SystemParticipants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy. |
| Perineal Plus Intraprostatic Local Anesthesia | Experimental | Drug: Prilocaine, Drug: Bupivacaine, Procedure: Perineal Local Anesthesia, Procedure: Intraprostatic Local Anesthesia, Procedure: Transperineal Prostate Biopsy, Device: Transrectal Ultrasound (TRUS) SystemParticipants receive standard perineal local anesthesia plus intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes before transperineal prostate biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 18 years or older
- Clinical indication for transperineal prostate biopsy based on elevated prostate-specific antigen (PSA) level and/or suspicious digital rectal examination findings
- Ability to understand and complete the Hospital Anxiety and Depression Scale (HADS)
- Ability to provide pain scores using a 10-point Visual Analog Scale (VAS)
- Provision of written informed consent
Key exclusion criteria (8 listed)
- Previous history of prostate biopsy
- Known hypersensitivity or contraindication to local anesthetic agents
- Hematological disorders affecting coagulation
- Active urinary tract infection
- Neurological disorders that may affect pain perception
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 |
|---|---|---|
| PrilocainePrilocaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group. | Drug | Perineal Local Anesthesia, Perineal Plus Intraprostatic Local Anesthesia |
| BupivacaineBupivacaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group. | Drug | Perineal Local Anesthesia, Perineal Plus Intraprostatic Local Anesthesia |
| Perineal Local AnesthesiaParticipants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy. | Procedure or surgery | Perineal Local Anesthesia, Perineal Plus Intraprostatic Local Anesthesia |
| Intraprostatic Local AnesthesiaParticipants receive intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes during transperineal prostate biopsy. | Procedure or surgery | Perineal Plus Intraprostatic Local Anesthesia |
| Transperineal Prostate BiopsyParticipants undergo standard transperineal prostate biopsy under local anesthesia according to the institutional biopsy protocol. | Procedure or surgery | Perineal Local Anesthesia, Perineal Plus Intraprostatic Local Anesthesia |
| Transrectal Ultrasound (TRUS) SystemA transrectal ultrasound (TRUS) system is used to provide real-time ultrasound guidance during transperineal prostate biopsy. The TRUS probe is inserted into the rectum to visualize the prostate and guide accurate needle placement through the perineum for systematic prostate biopsy under local anesthesia. The device is used in both study groups. | Device | Perineal Local Anesthesia, Perineal Plus Intraprostatic Local Anesthesia |
Primary outcome
Pain During Transperineal Prostate Biopsy
Time frame: During the biopsy procedure
Pain severity during transperineal prostate biopsy will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity. Pain scores will be compared between participants receiving perineal local anesthesia alone and those receiving additional intraprostatic local anesthesia.
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 6 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared in order to protect participant confidentiality and comply with ethical and institutional requirements. De-identified data may be made available upon reasonable request for scientifically and medically justified purposes, subject to review and approval by the principal investigator.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prilocaine, Bupivacaine and Perineal Local Anesthesia in people with Prostate Cancer (Diagnosis) and Prostate-Specific Antigen, run by Marmara University 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Transperineal Prostate Biopsy (time frame: During 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 6 Jul 2026.