Prostate CancerNCT02761135
Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?
An observational study of Prostate Cancer, run by Kronoberg County Council at 1 site in Sweden.
Trial summary
Prostate cancer is the most common cancer among men in Sweden. During investigation of suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to diagnosis. The most common technique today is side-fire where the needle enter the prostate in angle from the probe. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 364 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Mar 2018
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men admitted to Urological reception in Vaxjo and Ljungby for a first-time re-biopsy for investigating prostate cancer.
Who may be able to join
- first re-biopsy
- PSA over 3ng/ml
- T1c to T2a palpatory finding
Who cannot join
- prostate cancer
- T2b or more advanced cancer
- more than one previous biopsy done
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Section of Urology, Department of surgery, Regional Hospital Växjö
Vaxjo, Kronoberg County
About this study
Official title: Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique, in Investigating a Raised Prostatic Specific Antigen (PSA)?
Prostate cancer is the most common cancer among men in Sweden. During investigation of suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to diagnosis.
The most common technique today is side-fire where the needle enter the prostate in angle from the probe. In end-fire technique the needle enters the prostate at tip of probe without angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach the ventral and apical aspects of prostate.
Read more
Today´s standard is at least five cores from each side of the prostate at first biopsy. If first sample is negative there will usually be another urological exam and a first re-biopsy.
The study aim to compare these two methods in cancer detection. The investigators' hypothesis is that when using end-fire technique at first re-biopsy, investigators find more cancers compared to side-fire.
Patients are prospectively randomized into two groups, both assessing 12 core biopsies according to study protocol.
Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level, prostate size, digital rectal exam, hypoechogenic zones and length of cancers.
- Conditions
- Prostate Cancer
- Keywords
- Biopsy technique, Transrectal ultrasonography probe, Side-fire, Prostate cancer, End-fire
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Side-fire | Using side-fire technique during transrectal ultrasound. | |
| End-fire | Using end-fire technique during transrectal ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer detection
After finished study inclusion, data will be analyzed and presented within 12-18 months.
Measured: Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2011
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kronoberg County Council
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Joakim Ortegren, Principal investigator, Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761135
- Sponsor's protocol ID
- Endfirestudie
- Status last verified
- May 2018
- First submitted
- 21 May 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Ortegren J, Holmberg JT, Lekas E, Mana S, Martensson S, Richthoff J, Sundqvist P, Kjolhede H, Bratt O, Liedberg F. A randomised trial comparing two protocols for transrectal prostate repeat biopsy: six lateral posterior plus six anterior cores versus a standard posterior 12-core biopsy. Scand J Urol. 2019 Aug;53(4):217-221. doi: 10.1080/21681805.2019.1628102. Epub 2019 Jun 17.
PubMed 31204873
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique, in Investigating a Raised Prostatic Specific Antigen (PSA)?
- ClinicalTrials.gov ID
- NCT02761135
- Acronym / sponsor ID
- Endfirestudie
- Conditions
- Prostate Cancer
- Keywords
- Biopsy technique, Transrectal ultrasonography probe, Side-fire, Prostate cancer, End-fire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Kronoberg County CouncilOther government
- Study start
- Jan 2011
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 May 2016 (estimated)
- 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 cancer is the most common cancer among men in Sweden. During investigation of suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to diagnosis.
The most common technique today is side-fire where the needle enter the prostate in angle from the probe. In end-fire technique the needle enters the prostate at tip of probe without angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach the ventral and apical aspects of prostate.
Today´s standard is at least five cores from each side of the prostate at first biopsy. If first sample is negative there will usually be another urological exam and a first re-biopsy.
The study aim to compare these two methods in cancer detection. The investigators' hypothesis is that when using end-fire technique at first re-biopsy, investigators find more cancers compared to side-fire.
Patients are prospectively randomized into two groups, both assessing 12 core biopsies according to study protocol.
Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level, prostate size, digital rectal exam, hypoechogenic zones and length of cancers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side-fire | – | –Using side-fire technique during transrectal ultrasound. |
| End-fire | – | –Using end-fire technique during transrectal ultrasound. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men admitted to Urological reception in Vaxjo and Ljungby for a first-time re-biopsy for investigating prostate cancer.
Key inclusion criteria (3 listed)
- first re-biopsy
- PSA over 3ng/ml
- T1c to T2a palpatory finding
Key exclusion criteria (3 listed)
- prostate cancer
- T2b or more advanced cancer
- more than one previous biopsy done
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer detection
Time frame: Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.
After finished study inclusion, data will be analyzed and presented within 12-18 months.
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 22 May 2018.
- Derived from this study: PubMed 31204873Ortegren J, Holmberg JT, Lekas E, Mana S, Martensson S, Richthoff J, Sundqvist P, Kjolhede H, Bratt O, Liedberg F. A randomised trial comparing two protocols for transrectal prostate repeat biopsy: six lateral posterior plus six anterior cores versus a standard posterior 12-core biopsy. Scand J Urol. 2019 Aug;53(4):217-221. doi: 10.1080/21681805.2019.1628102. Epub 2019 Jun 17.
- Individual participant dataSharing planned: Yes
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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.
Joakim Ortegren principal investigator
Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden
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 Kronoberg County Council at 1 site in Sweden.
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 3 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 22 May 2018. 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 Sweden. 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?
Cancer detection (time frame: Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.). 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 NCT02761135, which also lists 1 linked publication.
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 22 May 2018.