Prostate BiopsyNORAPPNCT04146142
Transperineal MRI-TRUS Fusion Guided Prostate Biopsy With vs Without Antibiotic Prophylaxis
A study testing Transperineal prostate biopsy with or without antibiotic prophylaxis in people with Prostate Biopsy and Antibiotic, run by Oslo University Hospital at 2 sites in 2 countries.
Trial summary
Prostate biopsy is indicated in patients with suspected prostate cancer and has been traditionally performed through the rectum using antibiotic prophylaxis. Increasing antibiotic resistance of intestinal bacteria is causing a growing number of patients to get post-biopsy infections. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Biopsy, Antibiotic
- What is being tested?
- Transperineal prostate biopsy with or without antibiotic prophylaxis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Nov 2019to 30 Apr 2021
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- Patients with symptoms of urinary tract infection or positive findings on urine dipstic before biopsy
- Patients with indwelling urethral catheter
- Patients with immunodeficiency disorders
- Patients with high risk for infective endocarditis [European Society of Cardiology]
- Patients with a prosthetic aortic or pulmonary valve
- Patients with previous infective endocarditis
Show all 10Show fewer
- Patients with congenital heart disease who are cyanotic and those who have had palliative shunts/conduits/other prostheses
- Patients with a history of thromboembolic disease
- Patients with a history of allergy to the study drug
- Patients who do not wish to participate in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy
Prostate biopsy is indicated in patients with suspected prostate cancer and has been traditionally performed through the rectum using antibiotic prophylaxis. Increasing antibiotic resistance of intestinal bacteria is causing a growing number of patients to get post-biopsy infections. Sepsis rate after transrectal biopsies is approximately 4-10%.
To reduce the risk of post-biopsy infections, transperineal approach in general anesthesia and antibiotic prophylaxis has been used. The investigators at Oslo University Hospital Aker developed MRI -TURS elastic image fusion guided transperineal prostate biopsy technique in local anesthesia and Bactrim prophylaxis as outpatient procedure. The investigators found 0.4% post-biopsy infection rate. Afterwards a pilot study using the same biopsy technique however without antibiotic prophylaxis was realized in 90 patients. None of these subjects experienced infection.
The investigators wish to perform a prospective randomized trial of antibiotic prophylaxis versus none before transperineal MRI-TRUS fusion guided prostate biopsy in local anesthesia in outpatient clinic.
Read the detailed description
Background: Unnecessary use of antibiotics promotes antibiotic resistance. Efforts for antibiotic use reduction without increase the risk of serious infection complications are therefore needed.
Purpose: The aim of this trial is to compare the rates of infectious complication after transperineal prostate biopsy in patients with and without antibiotic prophylaxis.
Materials and methods: A total of 450 patients will be included in this trial. A 1:1 randomization to receive or not receive antibiotics prophylaxis will be performed using randomization system WebCRF-3 system. MRI-TRUS fusion prostate biopsy will be done with transperineal prostate approach in local anesthesia in outpatient clinic. In patients with normal MRI,12-core systematic prostate biopsies with 3D biopsy registration will be done according to the EAU guidelines. In patients with positive MRI, 2-4 targeted biopsies from the suspicious MRI areas will be realized and systematic prostate biopsies will also be done. All prostate biopsies will be performed using Koelis MRI-TRUS image fusion and organ based tracking system. Post-biopsy infection and any adverse events will be systematically prospectively registered in all patients. Pain during the local anesthesia application and during the biopsy procedure will be registered using Visual Analog Score, 10 points scale questionnaire.
- Conditions
- Prostate Biopsy, Antibiotic
- Being tested
- Transperineal prostate biopsy with or without antibiotic prophylaxis
- Keywords
- Prostate Cancer, Biopsy, Complication, Randomization
- 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 prostate biopsy with or without antibiotic prophylaxisProcedure or surgery
As described above.
| Study group | Role | What they receive |
|---|---|---|
| Transperineal prostate biopsy with antibiotic profylaxis | Active comparator | Cefuroxim 1.5 g will be applied intramuscularly before prostate biopsy Receives: Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis |
| Transperineal prostate biopsy without antibiotic profylaxis | Experimental | No antibiotics will be used before or after prostate biopsy Receives: Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sepsis
Post biopsy sepsis will be defined by SIRS criteria
Measured: Up to 30 days
Incidence of post biopsy urinary tract infection
Post biopsy urinary tract infection not demanding hospital admission within 30
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start11 Nov 2019
- Primary completion28 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study 1:1
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Eduard Baco, Oslo University Hospital
- Investigators
- Eduard Baco, MD, PhD, Principal investigator, Oslo University HospitalErik Rud, MD,PhD, Study chair, Oslo University HospitalKarsten Gunzel, MD, Study chair, Vivantes Klinkum Am Urban, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146142
- Sponsor's protocol ID
- 2019/1266
- Acronym
- NORAPP
- Status last verified
- Dec 2021
- First submitted
- 28 Oct 2019
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data generated during this study will be evaluated at Oslo University Hospital
Publications
Jacewicz M, Rud E, Lauritzen P, Baco E. Non-infectious adverse events of transperineal prostate biopsies performed under local anaesthesia. BJU Int. 2024 Aug;134(2):300-306. doi: 10.1111/bju.16383. Epub 2024 Apr 28.
PubMed 38679416Jacewicz 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy
- ClinicalTrials.gov ID
- NCT04146142
- Acronym / sponsor ID
- NORAPP / 2019/1266
- Conditions
- Prostate Biopsy, Antibiotic
- Keywords
- Prostate Cancer, Biopsy, Complication, Randomization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 31 Oct 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.
Prostate biopsy is indicated in patients with suspected prostate cancer and has been traditionally performed through the rectum using antibiotic prophylaxis. Increasing antibiotic resistance of intestinal bacteria is causing a growing number of patients to get post-biopsy infections. Sepsis rate after transrectal biopsies is approximately 4-10%.
To reduce the risk of post-biopsy infections, transperineal approach in general anesthesia and antibiotic prophylaxis has been used. The investigators at Oslo University Hospital Aker developed MRI -TURS elastic image fusion guided transperineal prostate biopsy technique in local anesthesia and Bactrim prophylaxis as outpatient procedure. The investigators found 0.4% post-biopsy infection rate. Afterwards a pilot study using the same biopsy technique however without antibiotic prophylaxis was realized in 90 patients. None of these subjects experienced infection.
The investigators wish to perform a prospective randomized trial of antibiotic prophylaxis versus none before transperineal MRI-TRUS fusion guided prostate biopsy in local anesthesia in outpatient clinic.
Detailed description
Background: Unnecessary use of antibiotics promotes antibiotic resistance. Efforts for antibiotic use reduction without increase the risk of serious infection complications are therefore needed.
Purpose: The aim of this trial is to compare the rates of infectious complication after transperineal prostate biopsy in patients with and without antibiotic prophylaxis.
Materials and methods: A total of 450 patients will be included in this trial. A 1:1 randomization to receive or not receive antibiotics prophylaxis will be performed using randomization system WebCRF-3 system. MRI-TRUS fusion prostate biopsy will be done with transperineal prostate approach in local anesthesia in outpatient clinic. In patients with normal MRI,12-core systematic prostate biopsies with 3D biopsy registration will be done according to the EAU guidelines. In patients with positive MRI, 2-4 targeted biopsies from the suspicious MRI areas will be realized and systematic prostate biopsies will also be done. All prostate biopsies will be performed using Koelis MRI-TRUS image fusion and organ based tracking system. Post-biopsy infection and any adverse events will be systematically prospectively registered in all patients. Pain during the local anesthesia application and during the biopsy procedure will be registered using Visual Analog Score, 10 points scale questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study 1:1
| Arm | Type | Receives |
|---|---|---|
| Transperineal prostate biopsy with antibiotic profylaxis | Active comparator | Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxisCefuroxim 1.5 g will be applied intramuscularly before prostate biopsy |
| Transperineal prostate biopsy without antibiotic profylaxis | Experimental | Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxisNo antibiotics will be used before or after prostate biopsy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (10 listed)
- Patients with symptoms of urinary tract infection or positive findings on urine dipstic before biopsy
- Patients with indwelling urethral catheter
- Patients with immunodeficiency disorders
- Patients with high risk for infective endocarditis [European Society of Cardiology]
- Patients with a history of thromboembolic disease
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 |
|---|---|---|
| Transperineal prostate biopsy with or without antibiotic prophylaxisAs described above. | Procedure or surgery | Transperineal prostate biopsy with antibiotic profylaxis, Transperineal prostate biopsy without antibiotic profylaxis |
Primary outcome
Incidence of sepsis
Time frame: Up to 30 days
Post biopsy sepsis will be defined by SIRS criteria
Incidence of post biopsy urinary tract infection
Time frame: Up to 30 days
Post biopsy urinary tract infection not demanding hospital admission within 30
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 7 Dec 2021.
- Derived from this study: PubMed 38679416Jacewicz M, Rud E, Lauritzen P, Baco E. Non-infectious adverse events of transperineal prostate biopsies performed under local anaesthesia. BJU Int. 2024 Aug;134(2):300-306. doi: 10.1111/bju.16383. Epub 2024 Apr 28.
- Derived from this study: PubMed 35839791Jacewicz 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.
- Individual participant dataSharing planned: No. All data generated during this study will be evaluated at Oslo University Hospital
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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.
Eduard Baco, MD, PhD principal investigator
Oslo University Hospital
Erik Rud, MD,PhD study chair
Oslo University Hospital
Karsten Gunzel, MD study chair
Vivantes Klinkum Am Urban, Berlin, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal prostate biopsy with or without antibiotic prophylaxis in people with Prostate Biopsy and Antibiotic, run by Oslo University Hospital at 2 sites in 2 countries.
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 1 inclusion and 10 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 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Norway. 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?
Incidence of sepsis (time frame: Up to 30 days). 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 NCT04146142, which also lists 2 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 7 Dec 2021.