Prostate CancerNCT06987071
Efficacy Of Acupuncture in Pain and Anxiety During Transperineal Prostate Biopsy: A Prospective, Randomized, Sham-Controlled Trial
A study testing Acupuncture in people with Prostate Cancer and Pain Management, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the efficacy of acupuncture in reducing pain and improving patient experience during transperineal prostate biopsy. Participants will be randomized to receive either acupuncture or sham acupuncture prior to the biopsy, in addition to standard local anesthesia. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Pain Management, Acupuncture Analgesia
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated for transperineal prostate biopsy (e.g., elevated PSA, abnormal digital rectal exam).
- Willing and able to provide written informed consent.
Who cannot join
- Known allergy or contraindication to acupuncture (e.g., bleeding disorder, needle phobia).
- Requirement for sedation or general anesthesia.
- Previous experience with acupuncture treatment.
- Severe psychiatric disorders or diagnosed anxiety disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Başakşehir Çam ve sakura City Hospita
Istanbul
About this study
This randomized controlled trial evaluates the efficacy of acupuncture in reducing pain and improving patient experience during transperineal prostate biopsy. Participants will be randomized to receive either acupuncture or sham acupuncture prior to the biopsy, in addition to standard local anesthesia. The primary outcome is pain, measured using the Visual Analog Scale (VAS), while secondary outcomes include anxiety, additional analgesic use, patient satisfaction, and adverse events.
Read the detailed description
Transperineal prostate biopsy is a standard diagnostic procedure for prostate cancer, often associated with pain and anxiety. Although local anesthesia is commonly used, it may not fully alleviate discomfort, and systemic medications can introduce side effects. Acupuncture, a traditional Chinese medicine technique, has demonstrated potential in managing procedural pain and reducing anxiety across various clinical settings. However, its specific efficacy for transperineal prostate biopsy remains underexplored.
This study aims to determine whether acupuncture, administered before the biopsy, can reduce pain, decrease anxiety, and enhance patient satisfaction compared to a sham procedure. Employing a randomized, single-blind design, the trial seeks to minimize bias and generate robust evidence regarding acupuncture's benefits in this context.
Participants will be randomly assigned to either the acupuncture group or the sham acupuncture group, with both receiving standard local anesthesia to ensure ethical care. Pain will be assessed using the Visual Analog Scale (VAS) at multiple time points, and anxiety will be measured with the State-Trait Anxiety Inventory (STAI). Additional outcomes include the use of supplementary analgesics, patient satisfaction, and any adverse events associated with the interventions.
The study's findings could inform clinical practice by introducing a complementary, non-pharmacological option for pain management during transperineal prostate biopsy, potentially improving patient comfort and reducing reliance on systemic medications.
The study protocol has been approved by the Institutional Review Board (IRB) of our hospital, and all participants will provide written informed consent prior to enrollment. Data will be collected and monitored by an independent data manager to ensure accuracy and patient safety.
- Being tested
- Acupuncture, sham acupuncture
- Keywords
- acupuncture, prostate cancer, transperineal prostat biopsy, acupuncture anesthesia
- Medical subject headings
- Prostatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Insertion of sterile, single-use needles at specific acupuncture points (LI4, PC6, ST36, SP6) for 20 minutes with manual stimulation, administered 30 minutes before the biopsy by a licensed acupuncturist.
sham acupunctureProcedure or surgery
Superficial needle insertion at non-acupuncture points without stimulation, administered 30 minutes before the biopsy, mimicking the acupuncture procedure without therapeutic intent.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Participants receive acupuncture at specific points (LI4, PC6, ST36, SP6) for 20 minutes with manual stimulation, 30 minutes before the biopsy, alongside standard local anesthesia. Receives: Procedure: Acupuncture |
| Sham Acupuncture | Sham comparator | Participants receive superficial needle insertion at non-acupuncture points without stimulation, 30 minutes before the biopsy, alongside standard local anesthesia. Receives: Procedure: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Visual Analog Scale (VAS), a 0-10 scale where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: Baseline, perioperative, 30 minutes post-biopsy, 2 hours post-biopsy.
Secondary outcomes (3)
Anxiety Level
State-Trait Anxiety Inventory (STAI), a validated questionnaire.
Measured: before and after 30 minutes of operation
Additional Analgesic Use
Type and dose of any additional pain medication required.
Measured: after biopsy in 8 hours
Adverse events
Any complications related to acupuncture or the biopsy procedure.
Measured: peri operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, single-blind, parallel-group trial. Participants are randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture 30 minutes prior to transperineal prostate biopsy. Both groups receive standard local anesthesia. Randomization is performed using a computer-generated sequence, and outcome assessors are blinded to group assignments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ihsan Memmi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987071
- Sponsor's protocol ID
- 357843951
- Status last verified
- Aug 2026
- First submitted
- 7 May 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hong A, Hemmingway S, Wetherell D, Dias B, Zargar H. Outpatient transperineal prostate biopsy under local anaesthesia is safe, well tolerated and feasible. ANZ J Surg. 2022 Jun;92(6):1480-1485. doi: 10.1111/ans.17593. Epub 2022 Mar 10.
PubMed 35274426Yang J, Xiong X, Wei Q, Yang L. Acupuncture: a promising adjuvant strategy for pain management among the patients with prostate cancer. BJU Int. 2024 Oct;134(4):664-665. doi: 10.1111/bju.16467. Epub 2024 Jul 17. No abstract available.
PubMed 39019800Lin FX, Chen Y, Xu ZP. Enhancing perioperative pain management: the integrative potential of acupuncture in urological surgery. BJU Int. 2024 Oct;134(4):667-668. doi: 10.1111/bju.16503. Epub 2024 Aug 6. No abstract available.
PubMed 39106982Wang J, Lei Y, Bao B, Yu X, Dai H, Chen F, Li H, Wang B. Acupuncture for pain caused by prostate cancer: Protocol for a systematic review. Medicine (Baltimore). 2019 Jan;98(2):e13954. doi: 10.1097/MD.0000000000013954.
PubMed 30633174
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Acupuncture in Pain and Anxiety During Transperineal Prostate Biopsy: A Prospective, Randomized, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT06987071
- Acronym / sponsor ID
- 357843951
- Keywords
- acupuncture, prostate cancer, transperineal prostat biopsy, acupuncture anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 May 2025 (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.
This randomized controlled trial evaluates the efficacy of acupuncture in reducing pain and improving patient experience during transperineal prostate biopsy. Participants will be randomized to receive either acupuncture or sham acupuncture prior to the biopsy, in addition to standard local anesthesia. The primary outcome is pain, measured using the Visual Analog Scale (VAS), while secondary outcomes include anxiety, additional analgesic use, patient satisfaction, and adverse events.
Detailed description
Transperineal prostate biopsy is a standard diagnostic procedure for prostate cancer, often associated with pain and anxiety. Although local anesthesia is commonly used, it may not fully alleviate discomfort, and systemic medications can introduce side effects. Acupuncture, a traditional Chinese medicine technique, has demonstrated potential in managing procedural pain and reducing anxiety across various clinical settings. However, its specific efficacy for transperineal prostate biopsy remains underexplored.
This study aims to determine whether acupuncture, administered before the biopsy, can reduce pain, decrease anxiety, and enhance patient satisfaction compared to a sham procedure. Employing a randomized, single-blind design, the trial seeks to minimize bias and generate robust evidence regarding acupuncture's benefits in this context.
Participants will be randomly assigned to either the acupuncture group or the sham acupuncture group, with both receiving standard local anesthesia to ensure ethical care. Pain will be assessed using the Visual Analog Scale (VAS) at multiple time points, and anxiety will be measured with the State-Trait Anxiety Inventory (STAI). Additional outcomes include the use of supplementary analgesics, patient satisfaction, and any adverse events associated with the interventions.
The study's findings could inform clinical practice by introducing a complementary, non-pharmacological option for pain management during transperineal prostate biopsy, potentially improving patient comfort and reducing reliance on systemic medications.
The study protocol has been approved by the Institutional Review Board (IRB) of our hospital, and all participants will provide written informed consent prior to enrollment. Data will be collected and monitored by an independent data manager to ensure accuracy and patient safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, single-blind, parallel-group trial. Participants are randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture 30 minutes prior to transperineal prostate biopsy. Both groups receive standard local anesthesia. Randomization is performed using a computer-generated sequence, and outcome assessors are blinded to group assignments.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Procedure: AcupunctureParticipants receive acupuncture at specific points (LI4, PC6, ST36, SP6) for 20 minutes with manual stimulation, 30 minutes before the biopsy, alongside standard local anesthesia. |
| Sham Acupuncture | Sham comparator | Procedure: sham acupunctureParticipants receive superficial needle insertion at non-acupuncture points without stimulation, 30 minutes before the biopsy, alongside standard local anesthesia. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indicated for transperineal prostate biopsy (e.g., elevated PSA, abnormal digital rectal exam).
- Willing and able to provide written informed consent.
Key exclusion criteria (4 listed)
- Known allergy or contraindication to acupuncture (e.g., bleeding disorder, needle phobia).
- Requirement for sedation or general anesthesia.
- Previous experience with acupuncture treatment.
- Severe psychiatric disorders or diagnosed anxiety disorder.
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 |
|---|---|---|
| AcupunctureInsertion of sterile, single-use needles at specific acupuncture points (LI4, PC6, ST36, SP6) for 20 minutes with manual stimulation, administered 30 minutes before the biopsy by a licensed acupuncturist. | Procedure or surgery | Acupuncture |
| sham acupunctureSuperficial needle insertion at non-acupuncture points without stimulation, administered 30 minutes before the biopsy, mimicking the acupuncture procedure without therapeutic intent. | Procedure or surgery | Sham Acupuncture |
Primary outcome
Pain Score
Time frame: Baseline, perioperative, 30 minutes post-biopsy, 2 hours post-biopsy.
Visual Analog Scale (VAS), a 0-10 scale where 0 represents no pain and 10 represents the worst pain imaginable.
3 secondary outcomes
Anxiety Level
Time frame: before and after 30 minutes of operation
Additional Analgesic Use
Time frame: after biopsy in 8 hours
Adverse events
Time frame: peri operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Results publication: PubMed 35274426Hong A, Hemmingway S, Wetherell D, Dias B, Zargar H. Outpatient transperineal prostate biopsy under local anaesthesia is safe, well tolerated and feasible. ANZ J Surg. 2022 Jun;92(6):1480-1485. doi: 10.1111/ans.17593. Epub 2022 Mar 10.
- Results publication: PubMed 39019800Yang J, Xiong X, Wei Q, Yang L. Acupuncture: a promising adjuvant strategy for pain management among the patients with prostate cancer. BJU Int. 2024 Oct;134(4):664-665. doi: 10.1111/bju.16467. Epub 2024 Jul 17. No abstract available.
- Results publication: PubMed 39106982Lin FX, Chen Y, Xu ZP. Enhancing perioperative pain management: the integrative potential of acupuncture in urological surgery. BJU Int. 2024 Oct;134(4):667-668. doi: 10.1111/bju.16503. Epub 2024 Aug 6. No abstract available.
- Results publication: PubMed 30633174Wang J, Lei Y, Bao B, Yu X, Dai H, Chen F, Li H, Wang B. Acupuncture for pain caused by prostate cancer: Protocol for a systematic review. Medicine (Baltimore). 2019 Jan;98(2):e13954. doi: 10.1097/MD.0000000000013954.
- Individual participant dataSharing planned: Undecided
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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 Acupuncture in people with Prostate Cancer and Pain Management, run by Medipol 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 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 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Score (time frame: Baseline, perioperative, 30 minutes post-biopsy, 2 hours post-biopsy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06987071, which also lists 4 linked publications.
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 18 Aug 2026.