Prostate CancerNCT06027203
Transperineal Versus Transrectal Prostate Biopsy
An observational study of Prostate Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). 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?
- prostate biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 923 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Apr 2023to 18 Jul 2023
- Phase
- Observational
- 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
Study population: All men who underwent a transrectal prostate biopsy between January 2017 and December 2018, and/or a transperineal prostate biopsy between January 2021 and December 2022 in the Urology department of MUMC+
Who may be able to join
- men who underwent prostate biopsy between 2017-2018 (transrectal)
- men who underwent prostate biopsy between 2012-2022 (transperineal)
Who cannot join
- positive urine culture before biopsy
- patients in the transrectal biopsy group who did not take the prescribed course of antibiotic prophylaxis
- incomplete medical dossier where the occurrence of a complication could not be assessed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?
Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the limited evidence regarding complication rates after their omission. However, the rising rates of antibiotic resistance is of concern. The aim of this study was to compare the complication and detection rates of freehand TP-PB without AP versus TR-PB with AP.
Methods: This single center retrospective study was performed in an academic hospital. TP-PB were introduced in 2019 and implemented as the main technique by late 2020. To compare the two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the effects of the initial learning curve during the transition period. Primary outcome measure was post-biopsy complications occurring within 2 weeks, focusing on infectious complications. Secondary outcome measures were detection rates and upgrading/reclassification in the repeat biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact or Chi-Squared test.
- Conditions
- Prostate Cancer
- Being tested
- prostate biopsy
- Keywords
- prostate biopsy, prostate cancer, transperineal, transrectal
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate biopsyProcedure or surgery
Prostate biopsy by either transrectal or transperineal technique
| Study group | Role | What they receive |
|---|---|---|
| transrectal biopsy | Not described Receives: Procedure: prostate biopsy | |
| transperineal biopsy | Not described Receives: Procedure: prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Urinary tract infections, urinary retention, hematuria
Measured: 2 weeks
Secondary outcomes (1)
Detection rate
Chance of detecting prostate cancer according to histopathology of needle biopsy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start15 Apr 2023
- Primary completion15 Jun 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 923 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027203
- Sponsor's protocol ID
- MUMC-Pbx23
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?
- ClinicalTrials.gov ID
- NCT06027203
- Acronym / sponsor ID
- MUMC-Pbx23
- Conditions
- Prostate Cancer
- Keywords
- prostate biopsy, prostate cancer, transperineal, transrectal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 923 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 7 Sep 2023 (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.
Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the limited evidence regarding complication rates after their omission. However, the rising rates of antibiotic resistance is of concern. The aim of this study was to compare the complication and detection rates of freehand TP-PB without AP versus TR-PB with AP.
Methods: This single center retrospective study was performed in an academic hospital. TP-PB were introduced in 2019 and implemented as the main technique by late 2020. To compare the two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the effects of the initial learning curve during the transition period. Primary outcome measure was post-biopsy complications occurring within 2 weeks, focusing on infectious complications. Secondary outcome measures were detection rates and upgrading/reclassification in the repeat biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact or Chi-Squared test.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transrectal biopsy | – | Procedure: prostate biopsy |
| transperineal biopsy | – | Procedure: prostate biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men who underwent a transrectal prostate biopsy between January 2017 and December 2018, and/or a transperineal prostate biopsy between January 2021 and December 2022 in the Urology department of MUMC+
Key inclusion criteria (2 listed)
- men who underwent prostate biopsy between 2017-2018 (transrectal)
- men who underwent prostate biopsy between 2012-2022 (transperineal)
Key exclusion criteria (3 listed)
- positive urine culture before biopsy
- patients in the transrectal biopsy group who did not take the prescribed course of antibiotic prophylaxis
- incomplete medical dossier where the occurrence of a complication could not be assessed
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 |
|---|---|---|
| prostate biopsyProstate biopsy by either transrectal or transperineal technique | Procedure or surgery | transperineal biopsy, transrectal biopsy |
Primary outcome
Complications
Time frame: 2 weeks
Urinary tract infections, urinary retention, hematuria
1 secondary outcome
Detection rate
Time frame: 2 weeks
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 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 3 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 Sep 2023. 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 Netherlands. 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?
Complications (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.