Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

Prostate Cancer Clinical Trial

Official title:

Infective Complications in Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359964
• Other study ID #: CRE2023.195
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: Peter Ka-Fung CHIU, PhD
• Phone: 35052625
• Email: peterchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis.

Description:

All consecutive patients receiving transperineal prostate biopsy in the PWH will be recruited to the exposure cohort after informed consent. Antibiotic prophylaxis will not be given for patients in the exposure group. All patients will undergo transperineal prostate biopsy in the usual manner and technique, under the Ginsburg protocol. Systematic and MRI-TRUS fusion for systematic plus targeted biopsy will be performed based on the usual clinical indications, depending on the clinical need. Follow-up data will be collected, with particular interest on the assessment of infective complications.

Prospectively collected data will also be retrieved from the electronic patient record (ePR) under the Hospital Authority, to assess relevant information on infective complications for patients who received transperineal prostate biopsy in PWH and NDH from 2019 to 2023. These patients received antibiotic prophylaxis prior to their biopsies, and eligible patients will be included as the control cohort for comparison. Propensity score matching will be utilized in order to create a control group that is similar to the exposure group with balanced baseline. Statistical analysis will be performed on the retrieve data.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1900
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients in participating centres receiving transperineal USG-guided biopsy for any indication including:

• Elevated PSA

• Abnormal DRE

• Follow-up biopsy in active surveillance

• Suspicion of CAP recurrence after radiotherapy

• Follow-up biopsy after focal therapy

• Consenting to the study

Exclusion Criteria:

• Recent suspected UTI within 1 month

• Recent culture proven bacteriuria within 1 month

• History of recurrent UTI

• Indwelling urinary catheter

• Immunocompromised state

• High risk of infective endocarditis (including prosthetic heart valve, congenital heart disease, or previous history of infective endocarditis

• Incompetent or incapable of understanding the nature of the study or giving informed consent

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Transperineal Biopsy without antibiotics prophylaxis
Transperineal Biopsy without antibiotics prophylaxis
• Transperineal Biopsy with antibiotics prophylaxis
Transperineal Biopsy with antibiotics prophylaxis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

References & Publications (9)

Basourakos SP, Alshak MN, Lewicki PJ, Cheng E, Tzeng M, DeRosa AP, Allaway MJ, Ross AE, Schaeffer EM, Patel HD, Hu JC, Gorin MA. Role of Prophylactic Antibiotics in Transperineal Prostate Biopsy: A Systematic Review and Meta-analysis. Eur Urol Open Sci. 2022 Jan 29;37:53-63. doi: 10.1016/j.euros.2022.01.001. eCollection 2022 Mar. — View Citation

Castellani D, Pirola GM, Law YXT, Gubbiotti M, Giulioni C, Scarcella S, Wroclawski ML, Chan E, Chiu PK, Teoh JY, Gauhar V, Rubilotta E. Infection Rate after Transperineal Prostate Biopsy with and without Prophylactic Antibiotics: Results from a Systematic Review and Meta-Analysis of Comparative Studies. J Urol. 2022 Jan;207(1):25-34. doi: 10.1097/JU.0000000000002251. Epub 2021 Sep 24. — View Citation

Derin O, Fonseca L, Sanchez-Salas R, Roberts MJ. Infectious complications of prostate biopsy: winning battles but not war. World J Urol. 2020 Nov;38(11):2743-2753. doi: 10.1007/s00345-020-03112-3. Epub 2020 Feb 24. — View Citation

Jacewicz M, Gunzel K, Rud E, Sandbaek G, Magheli A, Busch J, Hinz S, Baco E. Antibiotic prophylaxis versus no antibiotic prophylaxis in transperineal prostate biopsies (NORAPP): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2022 Oct;22(10):1465-1471. doi: 10.1016/S1473-3099(22)00373-5. Epub 2022 Jul 12. — View Citation

Kotel'nikov VP. [Current value of the deontologic principles of N. I. Pirogova]. Klin Med (Mosk). 1985 Nov;63(11):131-8. No abstract available. Russian. — View Citation

Li JKM, Wang LL, Lau BSY, Tse RTH, Cheng CKL, Leung SCH, Wong CYP, Tsui SKW, Teoh JYC, Chiu PKF, Ng CF. Oral antibiotics perturbation on gut microbiota after prostate biopsy. Front Cell Infect Microbiol. 2022 Aug 16;12:959903. doi: 10.3389/fcimb.2022.959903. eCollection 2022. — View Citation

Rassen JA, Shelat AA, Myers J, Glynn RJ, Rothman KJ, Schneeweiss S. One-to-many propensity score matching in cohort studies. Pharmacoepidemiol Drug Saf. 2012 May;21 Suppl 2:69-80. doi: 10.1002/pds.3263. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Singhal U, Qi J, Daignault-Newton S, George AK. Antibiotic prophylaxis for transperineal prostate biopsy? An unanswered question. Lancet Infect Dis. 2022 Dec;22(12):1662. doi: 10.1016/S1473-3099(22)00738-1. Epub 2022 Nov 7. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in UTI hospitalization rate between the two groups after biopsy	UTI hospitalization rate is defined symptomology requiring admission to an in-patient facility	Within 14 days of biopsy
Primary	The difference in urosepsis rates between the two groups after biopsy	Urosepsis is defined as sepsis of likely urological source either based on symptomology or bacteriology.	Within 14 days of biopsy
Secondary	Post-biopsy UTI rates between the two groups	The result of clean catch mid-stream urine for culture	At post-biopsy Day 14
Secondary	Assessment of bacteriology and antibiotic resistant profile between the two groups	The bacteriology and antibiotic resistant profile are assessed by clean-catch urine culture.	At post-biopsy Day 14