Pain Due to Certain Specified ProceduresNCT03859804

Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy

A study testing Standard transrectal 12 core biopsy and MRI- US fusion prostate biopsy (FPB) in people with Pain Due to Certain Specified Procedures and Prostate Cancer, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study was to compare the pain levels in transrectal ultrasound (TRUS)-guided standard 12-core prostate biopsy (SPB) and multiparametric prostate magnetic resonance imaging (MpMRI)-guided fusion prostate biopsy (FPB). Read more about this study

Who is it for?: Ages 50 to 75 years, men only
Conditions the study is for: Pain Due to Certain Specified Procedures, Prostate Cancer, Biopsy
What is being tested?: Standard transrectal 12 core biopsy and MRI- US fusion prostate biopsy (FPB)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Dec 2016to 1 Feb 2019
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 50 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Elevated blood prostate specific antigen (PSA) levels according to patients age. PSA >2ng/ml for whom aged between 50-60, and PSA >4ng/ml for whom were above 60 years old
Having suspicious digital rectal examination
having multi-parametric prostate MRI before prostate biopsy
Having MRI defined lesions which were PIRADS - 3 -4-5

Who cannot join

PSA > 50 ng/ml
previous negative biopsy
neurological disorders that could affect the pain level such as paraplegia or hemiplegia, analgesics use for any reason on the day of or the day before the procedure,
patients underwent biopsy under general anesthesia,
having such diseases as anal fissure or hemorrhoidal disease that could alter the pain threshold

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Read the detailed description

The study included patients that underwent prostate biopsy under local anesthesia (intrarectal 2% lidocaine gel + periprostatic nerve block) due to suspected prostate cancer. Patients detected with a Prostate Imaging Reporting and Data System score (PIRADS) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS <3 lesion on MpMRI underwent TRUS-guided SPB (Group II). Pain assessment was performed using Visual Analog Scale (VAS) 5 min after the procedure. Following the procedure, the patients were asked to indicate the most painful biopsy step among the three steps (1: insertion of the probe into the rectum, 2: probe manipulation, 3: the piercing of the biopsy needle).

Conditions: Pain Due to Certain Specified Procedures, Prostate Cancer, Biopsy
Being tested: Standard transrectal 12 core biopsy, MRI- US fusion prostate biopsy (FPB)
Keywords: fusion, prostate, biopsy, pain
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.

Standard transrectal 12 core biopsyProcedure or surgery
Also called Group 2
TRUS-guided SPB was performed by obtaining 12 core samples in each patient. 6 cores from left and right. the cores labeled as, apex, mid, base, apex far lateral, mid far lateral and base far lateral
MRI- US fusion prostate biopsy (FPB)Procedure or surgery
Also called Group 1
FPB was performed by obtaining 10-12 core samples in each patient, followed by the acquisition of 2-4 core samples for each suspected lesion detected on MpMRI (combined biopsy)

Study groups in NCT03859804
Study group	Role	What they receive
Group 1	Experimental	In Group 1, Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided MRI- US fusion prostate biopsy. In this fusion biopsy, 12 core standard biopsy and 2-4 cores of biopsies from lesions defined on multiparametric prostate MRI Receives: Procedure: MRI- US fusion prostate biopsy (FPB)
Group 2	Active comparator	In Group 2, patients who had no suspected lesions or had a PI-RADS <3 lesion on MpMRI underwent Transrectal ultrasound guided 12 core prostate biopsy (SPB). Receives: Procedure: Standard transrectal 12 core biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

To detect painful steps of biopsy procedure by asking patients verbally
to ask patients most painful step of procedure that verbally defined them before biopsy as 1: insertion of the probe into the rectum, 2: probe manipulation, and 3: the piercing of the biopsy needle
Measured: Within 5 minutes after biopsy
Over all Visual analogue Score (VAS) score of procedure(From 0 to 100 points, 100 is max pain score according to patient)
pain assessment was performed using Visual Analogue Scale (VAS)
Measured: Within 5 minutes after prostate biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20161 Feb 2019

First posted1 Mar 2019
Study start1 Dec 2016
Primary completion31 Jan 2019
Study completion1 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Pain Due to Certain Specified ProceduresStudies of the same condition, open and under way.
More trials run by TC Erciyes 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: Non-randomised
Intervention model: Parallel groups
Model description: pain levels after standard transrectal prostate 12 core biopsy and MRI -US fusion prostate biopsy were detected and compared in 2 groups.
Masking: None (open label)
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03859804
Sponsor's protocol ID: 2014/508
Status last verified: Feb 2019
First submitted: 24 Feb 2019
Last updated: 1 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842
Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.
PubMed 25626035
Gayet M, van der Aa A, Beerlage HP, Schrier BP, Mulders PF, Wijkstra H. The value of magnetic resonance imaging and ultrasonography (MRI/US)-fusion biopsy platforms in prostate cancer detection: a systematic review. BJU Int. 2016 Mar;117(3):392-400. doi: 10.1111/bju.13247. Epub 2015 Aug 28.
PubMed 26237632
Hwang SI, Lee HJ, Lee SE, Hong SK, Byun SS, Lee SC, Choe G. Value of MR-US fusion in guidance of repeated prostate biopsy in men with PSA < 10 ng/mL. Clin Imaging. 2019 Jan-Feb;53:1-5. doi: 10.1016/j.clinimag.2018.09.012. Epub 2018 Sep 22.
PubMed 30265884
Mannaerts CK, Kajtazovic A, Lodeizen OAP, Gayet M, Engelbrecht MRW, Jager GJ, Wijkstra H, de Reijke TM, Beerlage HP. The added value of systematic biopsy in men with suspicion of prostate cancer undergoing multiparametric MRI-targeted biopsy. Urol Oncol. 2019 May;37(5):298.e1-298.e9. doi: 10.1016/j.urolonc.2019.01.005. Epub 2019 Jan 17.
PubMed 30660493
Luan Y, Huang TB, Gu X, Zhou GC, Lu SM, Tao HZ, Liu BD, Ding XF. Effect of prostate volume on the peripheral nerve block anesthesia in the prostate biopsy: A strobe-compliant study. Medicine (Baltimore). 2016 Jul;95(28):e4184. doi: 10.1097/MD.0000000000004184.
PubMed 27428215
Fourcade A, Payrard C, Tissot V, Perrouin-Verbe MA, Demany N, Serey-Effeil S, Callerot P, Coquet JB, Doucet L, Deruelle C, Joulin V, Nonent M, Fournier G, Valeri A. The combination of targeted and systematic prostate biopsies is the best protocol for the detection of clinically significant prostate cancer. Scand J Urol. 2018 Jun;52(3):174-179. doi: 10.1080/21681805.2018.1438509. Epub 2018 Feb 20.
PubMed 29463177
Autorino R, De Sio M, Di Lorenzo G, Damiano R, Perdona S, Cindolo L, D'Armiento M. How to decrease pain during transrectal ultrasound guided prostate biopsy: a look at the literature. J Urol. 2005 Dec;174(6):2091-7. doi: 10.1097/01.ju.0000181212.51025.06.
PubMed 16280735
Mazdak H, Abtahi AM, Momeni F, Izadpanahi MH. A comparison of pain control and complications using three different ways of anesthesia in patients undergoing transrectal ultrasound-guided prostate biopsy. J Res Med Sci. 2018 Feb 20;23:17. doi: 10.4103/jrms.JRMS_639_17. eCollection 2018.
PubMed 29531569
Wang N, Fu Y, Ma H, Wang J, Gao Y. Advantages of caudal block over intrarectal local anesthesia plus periprostatic nerve block for transrectal ultrasound guided prostate biopsy. Pak J Med Sci. 2016 Jul-Aug;32(4):978-82. doi: 10.12669/pjms.324.9823.
PubMed 27648052
Yang Y, Liu Z, Wei Q, Cao D, Yang L, Zhu Y, Wei X, Tang Z, Liu L, Han P. The Efficiency and Safety of Intrarectal Topical Anesthesia for Transrectal Ultrasound-Guided Prostate Biopsy: A Systematic Review and Meta-Analysis. Urol Int. 2017;99(4):373-383. doi: 10.1159/000481830. Epub 2017 Oct 30.
PubMed 29084411
Alabi TO, Tijani KH, Adeyomoye AA, Jeje EA, Anunobi CC, Ogunjimi MA, Ojewola RW, Akanmu ON, Oliyide AE, Orakwe DE. Combined intrarectal lidocaine gel and periprostatic nerve block: A 'balanced' anaesthesia for transrectal ultrasound-guided prostate biopsy? Niger Postgrad Med J. 2018 Oct-Dec;25(4):252-256. doi: 10.4103/npmj.npmj_145_18.
PubMed 30588947
Collins GN, Lloyd SN, Hehir M, McKelvie GB. Multiple transrectal ultrasound-guided prostatic biopsies--true morbidity and patient acceptance. Br J Urol. 1993 Apr;71(4):460-3. doi: 10.1111/j.1464-410x.1993.tb15993.x.
PubMed 8499991
Hollingsworth JM, Miller DC, Wei JT. Local anesthesia in transrectal prostate biopsy. Urology. 2006 Jun;67(6):1283-4. doi: 10.1016/j.urology.2005.12.016.
PubMed 16765193
Robins D, Lipsky M, RoyChoudry A, Wenske S. Assessment of Discomfort and Pain in Patients Undergoing Fusion Magnetic Resonance Imaging-guided vs TRUS-guided Prostate Biopsy. Urology. 2018 Jun;116:30-34. doi: 10.1016/j.urology.2018.02.029. Epub 2018 Mar 12.
PubMed 29545039

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy
ClinicalTrials.gov ID: NCT03859804
Acronym / sponsor ID: 2014/508
Conditions: Pain Due to Certain Specified Procedures, Prostate Cancer, Biopsy
Keywords: fusion, prostate, biopsy, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: 1 Dec 2016 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 1 Mar 2019 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: pain levels after standard transrectal prostate 12 core biopsy and MRI -US fusion prostate biopsy were detected and compared in 2 groups.

Arm	Type	Receives
Group 1	Experimental	Procedure: MRI- US fusion prostate biopsy (FPB)In Group 1, Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided MRI- US fusion prostate biopsy. In this fusion biopsy, 12 core standard biopsy and 2-4 cores of biopsies from lesions defined on multiparametric prostate MRI
Group 2	Active comparator	Procedure: Standard transrectal 12 core biopsyIn Group 2, patients who had no suspected lesions or had a PI-RADS <3 lesion on MpMRI underwent Transrectal ultrasound guided 12 core prostate biopsy (SPB).

Who may qualify

Ages: 50 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Elevated blood prostate specific antigen (PSA) levels according to patients age. PSA >2ng/ml for whom aged between 50-60, and PSA >4ng/ml for whom were above 60 years old
Having suspicious digital rectal examination
having multi-parametric prostate MRI before prostate biopsy
Having MRI defined lesions which were PIRADS - 3 -4-5

Key exclusion criteria (5 listed)

PSA > 50 ng/ml
previous negative biopsy
neurological disorders that could affect the pain level such as paraplegia or hemiplegia, analgesics use for any reason on the day of or the day before the procedure,
patients underwent biopsy under general anesthesia,
having such diseases as anal fissure or hemorrhoidal disease that could alter the pain threshold

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
Standard transrectal 12 core biopsyAlso: Group 2TRUS-guided SPB was performed by obtaining 12 core samples in each patient. 6 cores from left and right. the cores labeled as, apex, mid, base, apex far lateral, mid far lateral and base far lateral	Procedure or surgery	Group 2
MRI- US fusion prostate biopsy (FPB)Also: Group 1FPB was performed by obtaining 10-12 core samples in each patient, followed by the acquisition of 2-4 core samples for each suspected lesion detected on MpMRI (combined biopsy)	Procedure or surgery	Group 1

Primary outcome

To detect painful steps of biopsy procedure by asking patients verbally
Time frame: Within 5 minutes after biopsy
to ask patients most painful step of procedure that verbally defined them before biopsy as 1: insertion of the probe into the rectum, 2: probe manipulation, and 3: the piercing of the biopsy needle
Over all Visual analogue Score (VAS) score of procedure(From 0 to 100 points, 100 is max pain score according to patient)
Time frame: Within 5 minutes after prostate biopsy
pain assessment was performed using Visual Analogue Scale (VAS)

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 1 Mar 2019.
Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Background: PubMed 25626035Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.
Background: PubMed 26237632Gayet M, van der Aa A, Beerlage HP, Schrier BP, Mulders PF, Wijkstra H. The value of magnetic resonance imaging and ultrasonography (MRI/US)-fusion biopsy platforms in prostate cancer detection: a systematic review. BJU Int. 2016 Mar;117(3):392-400. doi: 10.1111/bju.13247. Epub 2015 Aug 28.
Background: PubMed 30265884Hwang SI, Lee HJ, Lee SE, Hong SK, Byun SS, Lee SC, Choe G. Value of MR-US fusion in guidance of repeated prostate biopsy in men with PSA < 10 ng/mL. Clin Imaging. 2019 Jan-Feb;53:1-5. doi: 10.1016/j.clinimag.2018.09.012. Epub 2018 Sep 22.
Background: PubMed 30660493Mannaerts CK, Kajtazovic A, Lodeizen OAP, Gayet M, Engelbrecht MRW, Jager GJ, Wijkstra H, de Reijke TM, Beerlage HP. The added value of systematic biopsy in men with suspicion of prostate cancer undergoing multiparametric MRI-targeted biopsy. Urol Oncol. 2019 May;37(5):298.e1-298.e9. doi: 10.1016/j.urolonc.2019.01.005. Epub 2019 Jan 17.
Background: PubMed 27428215Luan Y, Huang TB, Gu X, Zhou GC, Lu SM, Tao HZ, Liu BD, Ding XF. Effect of prostate volume on the peripheral nerve block anesthesia in the prostate biopsy: A strobe-compliant study. Medicine (Baltimore). 2016 Jul;95(28):e4184. doi: 10.1097/MD.0000000000004184.
Background: PubMed 29463177Fourcade A, Payrard C, Tissot V, Perrouin-Verbe MA, Demany N, Serey-Effeil S, Callerot P, Coquet JB, Doucet L, Deruelle C, Joulin V, Nonent M, Fournier G, Valeri A. The combination of targeted and systematic prostate biopsies is the best protocol for the detection of clinically significant prostate cancer. Scand J Urol. 2018 Jun;52(3):174-179. doi: 10.1080/21681805.2018.1438509. Epub 2018 Feb 20.
Results publication: PubMed 16280735Autorino R, De Sio M, Di Lorenzo G, Damiano R, Perdona S, Cindolo L, D'Armiento M. How to decrease pain during transrectal ultrasound guided prostate biopsy: a look at the literature. J Urol. 2005 Dec;174(6):2091-7. doi: 10.1097/01.ju.0000181212.51025.06.
Results publication: PubMed 29531569Mazdak H, Abtahi AM, Momeni F, Izadpanahi MH. A comparison of pain control and complications using three different ways of anesthesia in patients undergoing transrectal ultrasound-guided prostate biopsy. J Res Med Sci. 2018 Feb 20;23:17. doi: 10.4103/jrms.JRMS_639_17. eCollection 2018.
Results publication: PubMed 27648052Wang N, Fu Y, Ma H, Wang J, Gao Y. Advantages of caudal block over intrarectal local anesthesia plus periprostatic nerve block for transrectal ultrasound guided prostate biopsy. Pak J Med Sci. 2016 Jul-Aug;32(4):978-82. doi: 10.12669/pjms.324.9823.
Results publication: PubMed 29084411Yang Y, Liu Z, Wei Q, Cao D, Yang L, Zhu Y, Wei X, Tang Z, Liu L, Han P. The Efficiency and Safety of Intrarectal Topical Anesthesia for Transrectal Ultrasound-Guided Prostate Biopsy: A Systematic Review and Meta-Analysis. Urol Int. 2017;99(4):373-383. doi: 10.1159/000481830. Epub 2017 Oct 30.
Results publication: PubMed 30588947Alabi TO, Tijani KH, Adeyomoye AA, Jeje EA, Anunobi CC, Ogunjimi MA, Ojewola RW, Akanmu ON, Oliyide AE, Orakwe DE. Combined intrarectal lidocaine gel and periprostatic nerve block: A 'balanced' anaesthesia for transrectal ultrasound-guided prostate biopsy? Niger Postgrad Med J. 2018 Oct-Dec;25(4):252-256. doi: 10.4103/npmj.npmj_145_18.
Individual participant dataSharing planned: No

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.

Abdullah T Demirtaş, MD principal investigator

Erciyes University Faculty of Medicine Department of Urolgoy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 1 Mar 2019. 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?

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?

To detect painful steps of biopsy procedure by asking patients verbally (time frame: Within 5 minutes after biopsy). The study lists 2 primary outcomes in all. 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 NCT03859804, which also lists 23 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 1 Mar 2019.