Prostatic CancerNCT05969704
Fusion Versus Cognitive MRI Targeted Prostatic Biopsy
A study testing MRI fusion targeted prostatic biopsy and MRI cognitive targeted prostatic biopsy in people with Prostatic Cancer, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of the present study is to compare the accuracy of Magnetic resonance imaging targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Cancer
- What is being tested?
- MRI fusion targeted prostatic biopsy and MRI cognitive targeted prostatic biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 31 Dec 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prostate biopsy-naïve men
- PSA levels of up to 20 ng/mL
- Multi-parametric prostate MRI revealed a PIRAD 4 or PIRAD 5.
Who cannot join
- PSA level greater than 20 ng/mL
- patient with history of TRUS biopsy
- patient diagnosed as cancer prostate or with distant metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Imaging Targeted (fusion) Versus Cognitive Prostatic Biopsy in Biopsy-naïve Suspected Cancer Prostate Patient a Comparison Study
The aim of the present study is to compare the accuracy of Magnetic resonance imaging targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient
Read the detailed description
Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide, counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer in men.
The clinical prostate cancer detection rate of TRUS-guided needle biopsies is only 25-30%. while more than 50% of cancers that require definitive treatment remain undetected during initial biopsies .
Clinical studies have shown that 75-80% of non-palpable carcinomas remain undetected during initial prostate biopsies.
Multi-parametric prostate MRI has a high sensitivity for the detection of prostate adenocarcinoma and has shown promise for targeted biopsy of lesions that may be missed on routine systematic trans -rectal ultrasound (TRUS) biopsy .
The most recent European Association of Urology guidelines recommend MRI before prostate biopsy for biopsy-naïve men with elevated PSA, the strength rating of the recommendation is weak.
A systematic 12-core trans-rectal ultrasound-guided systematic biopsy (TRUS-SB) is still carried out for biopsy-naïve men at present. However, the TRUS-SB technique has several limitations, including over-diagnosis of clinically insignificant prostate cancer (CISCa), under-diagnosis of clinically significant prostate cancer (CSCa), false negative biopsy results and biopsy-related complications, such as bleeding and infections .
Targeted prostate biopsies from MRI-suspicious lesions have been shown to improve the cancer detection rate (CDR) of CSCa compared with systematic TRUS-guided biopsies .
Currently, three biopsy techniques are used for TB from MRI-suspicious lesions: in-bore MRI biopsies, cognitive magnetic resonance imaging trans-rectal ultrasound fusion targeted biopsy (COG-TB) and software guided magnetic resonance imaging-ultrasound fusion targeted biopsies (MRUS-TB). Inbore MRI biopsies that are carried out with an MRI-compatible guidance device can target suspicious lesions accurately; however, such biopsies are time-consuming and expensive .
In the COG-TB technique, a physician samples a location that has been visually estimated using ultrasound and is considered to correspond to the location of a suspicious lesion that was detected on MRI. However, when the suspicious lesion is completely invisible (isoechoic or too small) on TRUS, the accuracy of such biopsies is likely reduced .
The accuracy of COG-TB might be influenced by multiple factors, including the alignment of prostate landmarks, the physician's experience and so on. for these reasons, MRUS-TB where software fuses the MRI images with real-time TRUS images to guide the operator to biopsy the suspicious lesions is more commonly carried out; however, the optimal TB method remains unclear.
- Conditions
- Prostatic Cancer
- Being tested
- MRI fusion targeted prostatic biopsy, MRI cognitive targeted prostatic biopsy
- Keywords
- fusion biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI fusion targeted prostatic biopsyProcedure or surgery
Also called fusion biopsy
combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal lesion of prostate in order to guide the biopsy needle into the abnormal lesion
MRI cognitive targeted prostatic biopsyProcedure or surgery
Also called cognitive biposy
the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from the lesion
| Study group | Role | What they receive |
|---|---|---|
| fusion biopsy | Active comparator | This biopsy procedure that combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal area of prostate in order to guide the biopsy needle into the abnormal area. A sample of tissue can then be taken and checked under a microscope for cancer. A fusion biopsy may help find prostate cancer cells that may be missed with other types of biopsies. It may help find cancer at an early stage and plan cancer treatment. Receives: Procedure: MRI fusion targeted prostatic biopsy |
| cognitive biopsy | Active comparator | the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from it Receives: Procedure: MRI cognitive targeted prostatic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of clinically significant prostate cancer
accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Shebl Mehanna, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969704
- Sponsor's protocol ID
- TRUS prostatic biopsy
- Status last verified
- Jan 2025
- First submitted
- 23 Jul 2023
- Last updated
- 23 Jan 2025
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Targeted (fusion) Versus Cognitive Prostatic Biopsy in Biopsy-naïve Suspected Cancer Prostate Patient a Comparison Study
- ClinicalTrials.gov ID
- NCT05969704
- Acronym / sponsor ID
- TRUS prostatic biopsy
- Conditions
- Prostatic Cancer
- Keywords
- fusion biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Aug 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.
The aim of the present study is to compare the accuracy of Magnetic resonance imaging targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient
Detailed description
Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide, counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer in men.
The clinical prostate cancer detection rate of TRUS-guided needle biopsies is only 25-30%. while more than 50% of cancers that require definitive treatment remain undetected during initial biopsies .
Clinical studies have shown that 75-80% of non-palpable carcinomas remain undetected during initial prostate biopsies.
Multi-parametric prostate MRI has a high sensitivity for the detection of prostate adenocarcinoma and has shown promise for targeted biopsy of lesions that may be missed on routine systematic trans -rectal ultrasound (TRUS) biopsy .
The most recent European Association of Urology guidelines recommend MRI before prostate biopsy for biopsy-naïve men with elevated PSA, the strength rating of the recommendation is weak.
A systematic 12-core trans-rectal ultrasound-guided systematic biopsy (TRUS-SB) is still carried out for biopsy-naïve men at present. However, the TRUS-SB technique has several limitations, including over-diagnosis of clinically insignificant prostate cancer (CISCa), under-diagnosis of clinically significant prostate cancer (CSCa), false negative biopsy results and biopsy-related complications, such as bleeding and infections .
Targeted prostate biopsies from MRI-suspicious lesions have been shown to improve the cancer detection rate (CDR) of CSCa compared with systematic TRUS-guided biopsies .
Currently, three biopsy techniques are used for TB from MRI-suspicious lesions: in-bore MRI biopsies, cognitive magnetic resonance imaging trans-rectal ultrasound fusion targeted biopsy (COG-TB) and software guided magnetic resonance imaging-ultrasound fusion targeted biopsies (MRUS-TB). Inbore MRI biopsies that are carried out with an MRI-compatible guidance device can target suspicious lesions accurately; however, such biopsies are time-consuming and expensive .
In the COG-TB technique, a physician samples a location that has been visually estimated using ultrasound and is considered to correspond to the location of a suspicious lesion that was detected on MRI. However, when the suspicious lesion is completely invisible (isoechoic or too small) on TRUS, the accuracy of such biopsies is likely reduced .
The accuracy of COG-TB might be influenced by multiple factors, including the alignment of prostate landmarks, the physician's experience and so on. for these reasons, MRUS-TB where software fuses the MRI images with real-time TRUS images to guide the operator to biopsy the suspicious lesions is more commonly carried out; however, the optimal TB method remains unclear.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fusion biopsy | Active comparator | Procedure: MRI fusion targeted prostatic biopsyThis biopsy procedure that combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal area of prostate in order to guide the biopsy needle into the abnormal area. A sample of tissue can then be taken and checked under a microscope for cancer. A fusion biopsy may help find prostate cancer cells that may be missed with other types of biopsies. It may help find cancer at an early stage and plan cancer treatment. |
| cognitive biopsy | Active comparator | Procedure: MRI cognitive targeted prostatic biopsythe biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from it |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- prostate biopsy-naïve men
- PSA levels of up to 20 ng/mL
- Multi-parametric prostate MRI revealed a PIRAD 4 or PIRAD 5.
Key exclusion criteria (3 listed)
- PSA level greater than 20 ng/mL
- patient with history of TRUS biopsy
- patient diagnosed as cancer prostate or with distant metastasis
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 |
|---|---|---|
| MRI fusion targeted prostatic biopsyAlso: fusion biopsycombines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal lesion of prostate in order to guide the biopsy needle into the abnormal lesion | Procedure or surgery | fusion biopsy |
| MRI cognitive targeted prostatic biopsyAlso: cognitive biposythe biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from the lesion | Procedure or surgery | cognitive biopsy |
Primary outcome
detection of clinically significant prostate cancer
Time frame: two weeks
accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer
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 23 Jan 2025.
- 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?
A study testing MRI fusion targeted prostatic biopsy and MRI cognitive targeted prostatic biopsy in people with Prostatic Cancer, run by Menoufia University at 1 site in Egypt.
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 23 Jan 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 Egypt. 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?
detection of clinically significant prostate cancer (time frame: two 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 23 Jan 2025.