NCT06359964

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,900

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
10mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Aug 2024Mar 2027

First Submitted

Initial submission to the registry

March 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 4, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

March 5, 2024

Last Update Submit

November 20, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Post-biopsy UTI rates between the two groups

    At post-biopsy Day 14

  • Assessment of bacteriology and antibiotic resistant profile between the two groups

    At post-biopsy Day 14

Study Arms (2)

TP BIospy without antibiotic prophylaxis

EXPERIMENTAL

Transperineal Biopsy without antibiotic prophylaxis

Procedure: Transperineal Biopsy without antibiotics prophylaxis

TP BIospy with antibiotic prophylaxis

ACTIVE COMPARATOR

Transperineal Biopsy with antibiotic prophylaxis

Procedure: Transperineal Biopsy with antibiotics prophylaxis

Interventions

Transperineal Biopsy without antibiotics prophylaxisPROCEDURE

Transperineal Biopsy without antibiotics prophylaxis

TP BIospy without antibiotic prophylaxis
Transperineal Biopsy with antibiotics prophylaxisPROCEDURE

Transperineal Biopsy with antibiotics prophylaxis

TP BIospy with antibiotic prophylaxis

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (9)

  • 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.

    PMID: 32095882BACKGROUND

  • 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.

    PMID: 36051239BACKGROUND

  • 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.

    PMID: 34555932BACKGROUND

  • 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.

    PMID: 35243391BACKGROUND

  • 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.

    PMID: 35839791BACKGROUND

  • 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.

    PMID: 36356605BACKGROUND

  • 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.

    PMID: 22552982BACKGROUND

  • 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.

    PMID: 3910956BACKGROUND

  • 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.

    PMID: 26903338BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Peter Ka-Fung CHIU, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ka-Fung CHIU, PhD

CONTACT

35052625peterchiu@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2024

First Posted

April 11, 2024

Study Start

August 4, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)