Prostate CancerNCT05818631
Cognitive Fusion Prostate Biopsy With Biparametric Magnetic Resonance in the Detection of Prostate Cancer
An observational study of Prostate Cancer and Prostate Cancer Diagnosis, run by José Joaquín Mira at 1 site in Spain.
Trial summary
The goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) > 4 ng/mL and a… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Diagnosis
- What is being tested?
- fusion cognitive prostate biopsy
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to Feb 2024
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study will be performed in the 17th department of the Valencian Community (San Juan de Alicante's Department). Main patients are those that visit the consultation room in the Urological department of the Hospital Universitario San Juan de Alicante.
Who may be able to join
- Male patients between 18 and 80 years
- BpMRI performed in a 3 months period before the prostatic biopsy
- First transrectal prostatic biopsy
- PSA > 4 ng/mL and < 20 ng/mL
- Patients acceptance to participate in the study signing a written specific informed consent
Who cannot join
- Not having all the inclusion criteria described
- Suspicious digital rectal examination of prostate cancer
- Previous urinary tract infection in the last six months, acute urinary retention or being a chronic carrier of bladder catheter
- Previous prostatic surgery in any of its variants
- Concomitant treatment with Luteinizing hormone-releasing hormone (LHRH) analogue, antiandrogens or 5-alfa-reductase inhibitors
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Miguel Hernández de Elche
Alicante, 03550
BARAA NAKDALI KASSAB, 663292199, baranakdali@hotmail.com
About this study
Official title: Determine the Validity as a Diagnostic Test of the Transrectal Prostate Biopsy With Cognitive Fusion Through Biparametric Magnetic Resonance in the Detection of Non-palpabe Prostate Cancer
The goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) > 4 ng/mL and a normal digital rectal examination and without a biopsy previous to the MRI. Secondary aims are:
- Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI.
- Develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpMRI.
Read the detailed description
In Spain, PCa is the most common cancer independently from gender and the third cause of death in man, below lung and colorectal cancer. Incidence and mortality increase progressively as age increases, hence, due to an older population, this is an outstanding sociosanitary concern.
PCa generally is asymptomatic, diagnosis is based on prostate biopsy in man with an elevated Prostate Specific Antigen (PSA) in blood test and/or a pathologic digital rectal examination.
Multiparametric Magnetic Resonance Imaging (MRImp) plays an important role in the diagnosis. It allows the visualization of the tumor, it values its agresitivity with a scale named "Prostate Imaging-Reporting and Data System" (PI-RADS v2 scale), and permits a directed biopsy to the suspicious lesion.
This tecnique is expensive and very uncomfortable for the patient due its duration (40 minutes) and because it uses intravenous (iv) contrast. Due to these reasons, it is difficult to assume by the sanitary system to perform this technique to every patient with PCa suspicion.
Biparametric MRI emerges as an alternative with a new protocol, performed with less image sequences (T2 and diffusion), cheaper, lasting less (just 15 minutes), and without the administration of iv contrast. Thus, this technique is more assumable by a public sanitary system.
- Conditions
- Prostate Cancer, Prostate Cancer Diagnosis
- Being tested
- fusion cognitive prostate 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.
fusion cognitive prostate biopsyDiagnostic test
Also called directed prostate biopsy
A standard transrectal prostatic biopsy will be performed to both groups. To the group with suspicious lesions in the MRI (PI-RADS 3-5), an added directed cognitive fusion biopsy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| MRI + | PI-RADS 3-5 Receives: Diagnostic Test: fusion cognitive prostate biopsy | |
| MRI - | PI-RADS 1-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic precision of Biparametric Magnetic Resonance Imaging: consecutive validation of two diagnostic tests for obtaining sensitivity, specificity, positive predictive value and negative predictive value of the biparametric magnetic resonance imaging
evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer in patients with biochemical suspicion of prostate cancer (Prostate Specific Antigen in blood test > 4 ng/mL) with a normal digital rectal examination and without a biopsy previous to the MRI
Measured: 1 hour
Secondary outcomes (1)
Validity of first directed transrectal prostatic biopsy: consecutive validation of two diagnostic tests for obtaining sensitivity, specificity, positive predictive value and negative predictive value of the biparametric magnetic resonance imaging
Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Mar 2021
- Primary completionMay 2023 (estimated)
- Study completionFeb 2024 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- José Joaquín Mira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818631
- Sponsor's protocol ID
- Prostate MRI FAST protocol
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- 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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Validity as a Diagnostic Test of the Transrectal Prostate Biopsy With Cognitive Fusion Through Biparametric Magnetic Resonance in the Detection of Non-palpabe Prostate Cancer
- ClinicalTrials.gov ID
- NCT05818631
- Acronym / sponsor ID
- Prostate MRI FAST protocol
- Conditions
- Prostate Cancer, Prostate Cancer Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- José Joaquín MiraUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 19 Apr 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 goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) > 4 ng/mL and a normal digital rectal examination and without a biopsy previous to the MRI. Secondary aims are:
- Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI.
- Develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpMRI.
Detailed description
In Spain, PCa is the most common cancer independently from gender and the third cause of death in man, below lung and colorectal cancer. Incidence and mortality increase progressively as age increases, hence, due to an older population, this is an outstanding sociosanitary concern.
PCa generally is asymptomatic, diagnosis is based on prostate biopsy in man with an elevated Prostate Specific Antigen (PSA) in blood test and/or a pathologic digital rectal examination.
Multiparametric Magnetic Resonance Imaging (MRImp) plays an important role in the diagnosis. It allows the visualization of the tumor, it values its agresitivity with a scale named "Prostate Imaging-Reporting and Data System" (PI-RADS v2 scale), and permits a directed biopsy to the suspicious lesion.
This tecnique is expensive and very uncomfortable for the patient due its duration (40 minutes) and because it uses intravenous (iv) contrast. Due to these reasons, it is difficult to assume by the sanitary system to perform this technique to every patient with PCa suspicion.
Biparametric MRI emerges as an alternative with a new protocol, performed with less image sequences (T2 and diffusion), cheaper, lasting less (just 15 minutes), and without the administration of iv contrast. Thus, this technique is more assumable by a public sanitary system.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI + | – | Diagnostic Test: fusion cognitive prostate biopsyPI-RADS 3-5 |
| MRI - | – | –PI-RADS 1-2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be performed in the 17th department of the Valencian Community (San Juan de Alicante's Department). Main patients are those that visit the consultation room in the Urological department of the Hospital Universitario San Juan de Alicante.
Key inclusion criteria (5 listed)
- Male patients between 18 and 80 years
- BpMRI performed in a 3 months period before the prostatic biopsy
- First transrectal prostatic biopsy
- PSA > 4 ng/mL and < 20 ng/mL
- Patients acceptance to participate in the study signing a written specific informed consent
Key exclusion criteria (5 listed)
- Not having all the inclusion criteria described
- Suspicious digital rectal examination of prostate cancer
- Previous urinary tract infection in the last six months, acute urinary retention or being a chronic carrier of bladder catheter
- Previous prostatic surgery in any of its variants
- Concomitant treatment with Luteinizing hormone-releasing hormone (LHRH) analogue, antiandrogens or 5-alfa-reductase inhibitors
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 |
|---|---|---|
| fusion cognitive prostate biopsyAlso: directed prostate biopsyA standard transrectal prostatic biopsy will be performed to both groups. To the group with suspicious lesions in the MRI (PI-RADS 3-5), an added directed cognitive fusion biopsy will be performed. | Diagnostic test | MRI + |
Primary outcome
Diagnostic precision of Biparametric Magnetic Resonance Imaging: consecutive validation of two diagnostic tests for obtaining sensitivity, specificity, positive predictive value and negative predictive value of the biparametric magnetic resonance imaging
Time frame: 1 hour
evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer in patients with biochemical suspicion of prostate cancer (Prostate Specific Antigen in blood test > 4 ng/mL) with a normal digital rectal examination and without a biopsy previous to the MRI
1 secondary outcome
Validity of first directed transrectal prostatic biopsy: consecutive validation of two diagnostic tests for obtaining sensitivity, specificity, positive predictive value and negative predictive value of the biparametric magnetic resonance imaging
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 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.
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 and Prostate Cancer Diagnosis, run by José Joaquín Mira at 1 site in Spain.
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 5 inclusion and 5 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 26 Apr 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 Spain. 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 BARAA NAKDALI KASSAB (663292199, baranakdali@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic precision of Biparametric Magnetic Resonance Imaging: consecutive validation of two diagnostic tests for obtaining sensitivity, specificity, positive predictive value and negative predictive value of the biparametric magnetic resonance imaging (time frame: 1 hour). 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 26 Apr 2023.