Prostate Cancer (Diagnosis)NCT04880681
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
A study testing Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. and Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000) in people with Prostate Cancer (Diagnosis), run by Region Skane at 1 site in Sweden.
Trial summary
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. and Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 17 May 2021to 28 Feb 2024
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for prostate biopsy
- Signed informed written consent
Who cannot join
- None (other than general contraindications for prostate biopsy or patient not willing to participate)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Helsingborg Hospital
Helsingborg, Skåne County, 254 37
Andreas Forsvall, MD, 0046 42 4063121, andreas.forsvall@med.lu.se
About this study
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.
Read the detailed description
Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer.
Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard Tru Cut biopsy needle in prostate biopsy.
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator., Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)
- Keywords
- Prostatic Neoplasms, Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Diseases
- Medical subject headings
- Prostatic Neoplasms, Disease, Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.Device
Also called prostate biopsy
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)Device
Also called prostate biopsy
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
| Study group | Role | What they receive |
|---|---|---|
| Novel needle | Experimental | Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. Receives: Device: Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. |
| Standard Tru Cut needle | Active comparator | Standard tru cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000). Receives: Device: Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate biopsy length (measured by pathologist)
Length of biopsy specimen in millimeters
Measured: within 21 days post biopsy
Secondary outcomes (4)
Prostate biopsy fragmentation
The number of sections the biopsy specimen is made of
Measured: within 21 days post biopsy
General appearance of biopsy assessed by pathologist (biopsy quality)
General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)
Measured: within 21 days post biopsy
Prostate biopsy length (measured in biopsy needle chamber)
Length of biopsy specimen in millimeters
Measured: within 21 days post biopsy
Prostate biopsy length (measured after removal from biopsy chamber)
Length of biopsy specimen in millimeters
Measured: within 21 days post biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start17 May 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
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 Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients eligible for prostate biopsy are randomized into 2 arms (30+30 patients) using either the novel needle and actuator device or standard Tru Cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy length (primary outcome) is evaluated by a pathologist who is blinded to device used.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Linder, Ass prof, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880681
- Sponsor's protocol ID
- double needle
- Status last verified
- Apr 2023
- First submitted
- 5 May 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forsvall A, Fisher J, Wagenius M, Broman C, Korkocic D, Bratt O, Linder A. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial. Scand J Urol. 2021 Jun;55(3):235-241. doi: 10.1080/21681805.2021.1921024. Epub 2021 May 17.
PubMed 33999764Forsvall A, Fisher J, Cardoso JFP, Wagenius M, Tverring J, Nilson B, Dahlin A, Bratt O, Linder A, Mohanty T. Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy - a novel needle design with the objective to reduce the risk of post-biopsy infection. Scand J Urol. 2021 Jun;55(3):227-234. doi: 10.1080/21681805.2021.1921023. Epub 2021 May 17.
PubMed 33999753
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
- ClinicalTrials.gov ID
- NCT04880681
- Acronym / sponsor ID
- double needle
- Conditions
- Prostate Cancer (Diagnosis)
- Keywords
- Prostatic Neoplasms, Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 11 May 2021 (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.
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.
Detailed description
Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer.
Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard Tru Cut biopsy needle in prostate biopsy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 60 patients eligible for prostate biopsy are randomized into 2 arms (30+30 patients) using either the novel needle and actuator device or standard Tru Cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy length (primary outcome) is evaluated by a pathologist who is blinded to device used.
| Arm | Type | Receives |
|---|---|---|
| Novel needle | Experimental | Device: Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. |
| Standard Tru Cut needle | Active comparator | Device: Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)Standard tru cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for prostate biopsy
- Signed informed written consent
Key exclusion criteria (1 listed)
- None (other than general contraindications for prostate biopsy or patient not willing to participate)
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 |
|---|---|---|
| Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.Also: prostate biopsyTrans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient. | Device | Novel needle |
| Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)Also: prostate biopsyTrans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient. | Device | Standard Tru Cut needle |
Primary outcome
Prostate biopsy length (measured by pathologist)
Time frame: within 21 days post biopsy
Length of biopsy specimen in millimeters
4 secondary outcomes
Prostate biopsy fragmentation
Time frame: within 21 days post biopsy
General appearance of biopsy assessed by pathologist (biopsy quality)
Time frame: within 21 days post biopsy
Prostate biopsy length (measured in biopsy needle chamber)
Time frame: within 21 days post biopsy
Prostate biopsy length (measured after removal from biopsy chamber)
Time frame: within 21 days post biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Results publication: PubMed 33999764Forsvall A, Fisher J, Wagenius M, Broman C, Korkocic D, Bratt O, Linder A. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial. Scand J Urol. 2021 Jun;55(3):235-241. doi: 10.1080/21681805.2021.1921024. Epub 2021 May 17.
- Results publication: PubMed 33999753Forsvall A, Fisher J, Cardoso JFP, Wagenius M, Tverring J, Nilson B, Dahlin A, Bratt O, Linder A, Mohanty T. Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy - a novel needle design with the objective to reduce the risk of post-biopsy infection. Scand J Urol. 2021 Jun;55(3):227-234. doi: 10.1080/21681805.2021.1921023. Epub 2021 May 17.
- Forsvall et al. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial.Link provided by the sponsor.
- Forsvall et al, Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Adam Linder, Ass prof principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. and Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000) in people with Prostate Cancer (Diagnosis), run by Region Skane 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Forsvall (0046-42-4063121, andreas.forsvall@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate biopsy length (measured by pathologist) (time frame: within 21 days post biopsy). 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 NCT04880681, 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 1 May 2023.