AzTrials
AzTrials

Prostate CancerNCT06359964

Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

A study testing Transperineal Biopsy without antibiotics prophylaxis and Transperineal Biopsy with antibiotics prophylaxis in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

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

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Transperineal Biopsy without antibiotics prophylaxis and Transperineal Biopsy with antibiotics prophylaxis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,753 participants
Where
1 siteHong Kong
Study dates
4 Aug 2024to 13 Mar 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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

About this study

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

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.

Read the detailed 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.

Conditions
Prostate Cancer
Being tested
Transperineal Biopsy without antibiotics prophylaxis, Transperineal Biopsy with antibiotics prophylaxis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transperineal Biopsy without antibiotics prophylaxisProcedure or surgery

    Transperineal Biopsy without antibiotics prophylaxis

  • Transperineal Biopsy with antibiotics prophylaxisProcedure or surgery

    Transperineal Biopsy with antibiotics prophylaxis

Study groups in NCT06359964
Study groupRoleWhat they receive
TP BIospy without antibiotic prophylaxisExperimentalTransperineal Biopsy without antibiotic prophylaxis
Receives: Procedure: Transperineal Biopsy without antibiotics prophylaxis
TP BIospy with antibiotic prophylaxisActive comparatorTransperineal Biopsy with antibiotic prophylaxis
Receives: Procedure: Transperineal Biopsy with antibiotics prophylaxis

What is being measured

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

  1. 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

    Measured: Within 14 days of biopsy

  2. 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.

    Measured: Within 14 days of biopsy

Secondary outcomes (2)

  1. Post-biopsy UTI rates between the two groups

    The result of clean catch mid-stream urine for culture

    Measured: At post-biopsy Day 14

  2. Assessment of bacteriology and antibiotic resistant profile between the two groups

    The bacteriology and antibiotic resistant profile are assessed by clean-catch urine culture.

    Measured: At post-biopsy Day 14

Timeline

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

  1. First posted11 Apr 2024
  2. Study start4 Aug 2024
  3. Primary completion13 Mar 2025
  4. Study completion13 Mar 2025

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,753 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359964
Sponsor's protocol ID
CRE2023.195
Status last verified
Jun 2026
First submitted
5 Mar 2024
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32095882

  • 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.

    PubMed 36051239

  • 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.

    PubMed 34555932

  • 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.

    PubMed 35243391

  • 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.

    PubMed 35839791

  • 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.

    PubMed 36356605

  • 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.

    PubMed 22552982

  • 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.

    PubMed 3910956

  • 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.

    PubMed 26903338

Questions about this trial

What is this clinical trial studying?

A study testing Transperineal Biopsy without antibiotics prophylaxis and Transperineal Biopsy with antibiotics prophylaxis in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 7 inclusion and 7 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 24 Jun 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 Hong Kong. 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?

The difference in UTI hospitalization rate between the two groups after biopsy (time frame: Within 14 days of 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 NCT06359964, which also lists 9 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 24 Jun 2026.

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