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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859804
• Other study ID #: 2014/508
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: February 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Biopsy
• Pain Due to Certain Specified Procedures
• Prostate Cancer

Intervention

Procedure:
• Standard transrectal 12 core biopsy
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)
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)

Locations

Country	Name	City	State
Turkey	Department of Urology, Ercieys University, Faculty Of Medicine,	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (23)

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 — View Citation

Arsov C, Rabenalt R, Quentin M, Hiester A, Blondin D, Albers P, Antoch G, Schimmöller L. Comparison of patient comfort between MR-guided in-bore and MRI/ultrasound fusion-guided prostate biopsies within a prospective randomized trial. World J Urol. 2016 F — View Citation

Autorino R, De Sio M, Di Lorenzo G, Damiano R, Perdonà 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. Review. — View Citation

Bastide C, Lechevallier E, Eghazarian C, Ortega JC, Coulange C. Tolerance of pain during transrectal ultrasound-guided biopsy of the prostate: risk factors. Prostate Cancer Prostatic Dis. 2003;6(3):239-41. — View Citation

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. — View Citation

Djavan B, Waldert M, Zlotta A, Dobronski P, Seitz C, Remzi M, Borkowski A, Schulman C, Marberger M. Safety and morbidity of first and repeat transrectal ultrasound guided prostate needle biopsies: results of a prospective European prostate cancer detectio — View Citation

Fabiani A, Servi L, Filosa A, Fioretti F, Maurelli V, Tombolini F, Tallè M, Mammana G. May ultrasound probe size influence pain perception of needle piercing during transrectal prostate biopsy? A prospective evaluation. Arch Ital Urol Androl. 2016 Oct 5;8 — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Gómez-Gómez E, Ramírez M, Gómez-Ferrer A, Rubio-Briones J, Iborra I, J Carrasco-Valiente, Campos JP, Ruiz-García J, Requena-Tapia MJ, Solsona E. Assessment and clinical factors associated with pain in patients undergoing transrectal prostate biopsy. Actas — View Citation

Hollingsworth JM, Miller DC, Wei JT. Local anesthesia in transrectal prostate biopsy. Urology. 2006 Jun;67(6):1283-4. Review. — View Citation

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. — View Citation

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. — View Citation

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 Jan 16. pii: S1078-1439(19)30005-5. doi: 10.1016/j.urolonc.2019.01.005. [Epub ahead of print] — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

Urabe F, Kimura T, Shimomura T, Onuma H, Yamamoto T, Sasaki H, Miki J, Kuruma H, Miki K, Egawa S. Prospective comparison of the efficacy of caudal versus periprostatic nerve block, both with intrarectal local anesthesia, during transrectal ultrasonography — View Citation

Valdez-Flores RA, Campos-Salcedo JG, Torres-Gomez JJ, Sedano-Lozano A, Parés-Hipólito J, Shelton LM, Canizalez-Román A, Valdez-Flores MA. Prospective comparison among three intrarectal anesthetic treatments combined with periprostatic nerve block during t — View Citation

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. — View Citation

Yan P, Wang XY, Huang W, Zhang Y. Local anesthesia for pain control during transrectal ultrasound-guided prostate biopsy: a systematic review and meta-analysis. J Pain Res. 2016 Oct 11;9:787-796. eCollection 2016. — View Citation

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. do — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 5 minutes after biopsy
Primary	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)	Within 5 minutes after prostate biopsy