Prostate Cancer DiagnosisTARGETNCT06420115
Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
A study testing different needle size for prostate biopsy in people with Prostate Cancer Diagnosis, run by University Hospital Padova at 1 site in Italy.
Trial summary
Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Diagnosis
- What is being tested?
- different needle size for prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
- Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.
Who cannot join
- Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
- Previous radiotherapy to the prostate for neoplasia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Urology Unit - Padua University Hospital
Padua, Italy, 35100
Fabio Zattoni, MD, PhD, fabio.zattoni@unipd.it
Filippo Carletti, MD, filippo.carletti@aopd.veneto.it
About this study
Official title: AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer
Read the detailed description
To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.
- Conditions
- Prostate Cancer Diagnosis
- Being tested
- different needle size for prostate biopsy
- Keywords
- pca, needle, 16 gauge, 18 gauge
- Medical subject headings
- Choanal Atresia, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different needle size for prostate biopsyDevice
MRI Fusion Transperineal Prostate Biopsy
| Study group | Role | What they receive |
|---|---|---|
| mpMRI target prostate biopsy with 16 gauge needle | Experimental | Not described Receives: Device: different needle size for prostate biopsy |
| mpMRI target prostate biopsy with 18 gauge needle | Experimental | Not described Receives: Device: different needle size for prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of random and fusion-target biopsies with presence of prostate cancer
The primary outcome measure involves assessing the total number of biopsies, including both random and fusion-targeted approaches, that reveal the presence of prostate cancer.
Measured: When histological report available
Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2)
The primary outcome measure focuses on the number and the detection rates of random and fusion-target biopsies revealing clinically significant prostate cancer aof clinically significant prostate cancer (defined as ISUP >=2) between 16-gauge and 18-gauge biopsy needles.
Measured: When histological report available
Secondary outcomes (4)
Neoplasia/core ratio for each random and fusion-target biopsy
Neoplasia/core ratio, indicates the ratio of neoplastic tissue to healthy tissue within biopsy cores obtained through both 16 and 18 gauge biopsies for prostate cancer diagnosis. By analyzing this ratio, investivators seek to identify differences in diagnosis across the two different sizes
Measured: When histological report available
Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)
The validated pain questionnaire employed in this study is designed to comprehensively assess the intra- and perioperative pain (following 7 days) experienced by patients undergoing prostate biopsy procedures with 18G and 16G needles. The visual analog scales "VAS" is a standardized validated questionnaire, a horizontal line, where one end represents "1 - no pain" and the other end represents "10 - worst possible pain." Patients are asked to mark on the line the point that best represents the intensity of their pain.
Measured: 30 days
Number of hospitalizations at 30 and 60 days post-procedure
By tracking the number of hospitalizations occurring at both 30 and 60 days post-procedure among patients undergoing prostate biopsy within these specific time frames, researchers seek to assess the short-term post-procedural outcomes and potential complications associated with the biopsy procedure. These hospitalization data will provide information into the safety profile and healthcare utilization patterns following prostate biopsy, aiding in the optimization of patient care and risk management strategies.
Measured: 60 days from biopsy
Number of intra- and perioperative complications associated with 18G and 16G needles
Intraoperative complications refer to adverse events occurring during the biopsy procedure itself, while perioperative complications encompass those arising in the immediate post-procedural period. These complications may include but are not limited to bleeding, infection, urinary retention, and vasovagal reactions. By documenting these complications, investigators will evaluate the safety profile and potential risks associated with each needle gauge, thereby informing clinical decision-making and optimizing patient outcomes.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer DiagnosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FABIO ZATTONI, University Hospital Padova
- Investigators
- Fabio Zattoni, MD, PhD, Principal investigator, Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420115
- Sponsor's protocol ID
- AOP2780
- Acronym
- TARGET
- Status last verified
- Mar 2025
- First submitted
- 26 Apr 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only if requested
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
- ClinicalTrials.gov ID
- NCT06420115
- Acronym / sponsor ID
- TARGET / AOP2780
- Conditions
- Prostate Cancer Diagnosis
- Keywords
- pca, needle, 16 gauge, 18 gauge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 17 May 2024 (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.
Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer
Detailed description
To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mpMRI target prostate biopsy with 16 gauge needle | Experimental | Device: different needle size for prostate biopsy |
| mpMRI target prostate biopsy with 18 gauge needle | Experimental | Device: different needle size for prostate biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
- Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.
Key exclusion criteria (2 listed)
- Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
- Previous radiotherapy to the prostate for neoplasia.
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 |
|---|---|---|
| different needle size for prostate biopsyMRI Fusion Transperineal Prostate Biopsy | Device | mpMRI target prostate biopsy with 16 gauge needle, mpMRI target prostate biopsy with 18 gauge needle |
Primary outcome
Total number of random and fusion-target biopsies with presence of prostate cancer
Time frame: When histological report available
The primary outcome measure involves assessing the total number of biopsies, including both random and fusion-targeted approaches, that reveal the presence of prostate cancer.
Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2)
Time frame: When histological report available
The primary outcome measure focuses on the number and the detection rates of random and fusion-target biopsies revealing clinically significant prostate cancer aof clinically significant prostate cancer (defined as ISUP >=2) between 16-gauge and 18-gauge biopsy needles.
4 secondary outcomes
Neoplasia/core ratio for each random and fusion-target biopsy
Time frame: When histological report available
Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)
Time frame: 30 days
Number of hospitalizations at 30 and 60 days post-procedure
Time frame: 60 days from biopsy
Number of intra- and perioperative complications associated with 18G and 16G needles
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No. Only if requested
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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.
Fabio Zattoni, MD, PhD principal investigator
Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different needle size for prostate biopsy in people with Prostate Cancer Diagnosis, run by University Hospital Padova at 1 site in Italy.
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 2 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio F. Zattoni, MD, PhD (0498212730, fabio.zattoni@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of random and fusion-target biopsies with presence of prostate cancer (time frame: When histological report available). 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?
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 25 Mar 2025.