Prostate Cancer (Adenocarcinoma)NCT06774781
Assessment of ADC Values and Radiomics Characteristics With a MRI of the Prostate to Identify Tumor Lesions
An observational study of Prostate Cancer (Adenocarcinoma), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to assess the chance to predict prostate cancer with the analysis of specific values found in images obtained from RMmp (multiparametric magnetic resonance imaging) of patients who went through the procedure at IRCCS Azienda Ospedaliero-Universitaria hospital in the city of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 23 Oct 2021to 31 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include all participants who have performed a fusion biopsy with RMmp of the prostate in the period between the beginning of use of this technique (September 2015) and March 2021 whose images are available on RIS-PACS of the IRCCS University Hospital of Bologna will be included in the study . The sample size considered sufficient is 120 patients, of which 90 will be used for method development and 30 will be used as validation group. The latter will be used to evaluate how generalizable the results of the study are to the population, to avoid overestimating the model's capabilities in evaluating it on the same patients on which it was developed.
Who may be able to join
- Presence of one or more lesions classified as PI-RADSv2.1 ≥ 3 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
- Indication for eco-guided targeted biopsy by fusion technique integrated with systematic biopsy
- Indication for radical prostatectomy
- Participants aged 18 at the time of examination
- Obtaining informed consent.
Who cannot join
- Impossibility of performing MRI (claustrophobic or obese participants etc.) or contraindications to the execution of MRI
- Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Caterina Gaudiano, MD, 39 0512142307, caterina.gaudiano@aosp.bo.it
About this study
Official title: Assessment of the Distribution of ADC Values and Radiometric Characteristics of Suspect Areas With a Multiparametric MRI of the Prostate to Identify Clinically Significant Neoplastic Lesions
The goal of this observational study is to assess the chance to predict prostate cancer with the analysis of specific values found in images obtained from RMmp (multiparametric magnetic resonance imaging) of patients who went through the procedure at IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna from September 2015 to March 2021.
The main question it aims to answer is:
- does the analysis of ADC values and radiomics values found in the RMmp images help with the detection of prostate cancer?
Read the detailed description
The radiologist involved in this observational study will enroll the participants, collect their informed consent and radiological data.
The urologist will collect the clinical data while the Anatomo-pathologist will take care of the hystological data.
The ADC values of the suspected lesions and healthy parenchyma will be extracted from the MR exams. For the evaluation of radiometric characteristics, images will first be de-identified, the downloaded and processed by the hospital's medical physicists.
The engineers at the University of Bologna, led by medical investigators, will extract the radiomic characteristics All data will be anonymised and collected in a database shared between the collaborating operational units.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Radiomics, mpMRI
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of ADC
Evaluate the distribution of ADC values of the prostatic lesions cataloged according to the criteria PI-RADSv2.1 ≥ 3, comparing it with the distribution of ADC values of the healthy glandular tissue, to define a predictive threshold value for clinically significant neoplastic lesion.
Measured: From enrollment to the end of treatment at 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start23 Oct 2021
- Primary completion31 Dec 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caterina Gaudiano, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774781
- Sponsor's protocol ID
- PROSTATE_01_2021
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Distribution of ADC Values and Radiometric Characteristics of Suspect Areas With a Multiparametric MRI of the Prostate to Identify Clinically Significant Neoplastic Lesions
- ClinicalTrials.gov ID
- NCT06774781
- Acronym / sponsor ID
- PROSTATE_01_2021
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Radiomics, mpMRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 23 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 14 Jan 2025 (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 observational study is to assess the chance to predict prostate cancer with the analysis of specific values found in images obtained from RMmp (multiparametric magnetic resonance imaging) of patients who went through the procedure at IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna from September 2015 to March 2021.
The main question it aims to answer is:
- does the analysis of ADC values and radiomics values found in the RMmp images help with the detection of prostate cancer?
Detailed description
The radiologist involved in this observational study will enroll the participants, collect their informed consent and radiological data.
The urologist will collect the clinical data while the Anatomo-pathologist will take care of the hystological data.
The ADC values of the suspected lesions and healthy parenchyma will be extracted from the MR exams. For the evaluation of radiometric characteristics, images will first be de-identified, the downloaded and processed by the hospital's medical physicists.
The engineers at the University of Bologna, led by medical investigators, will extract the radiomic characteristics All data will be anonymised and collected in a database shared between the collaborating operational units.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all participants who have performed a fusion biopsy with RMmp of the prostate in the period between the beginning of use of this technique (September 2015) and March 2021 whose images are available on RIS-PACS of the IRCCS University Hospital of Bologna will be included in the study . The sample size considered sufficient is 120 patients, of which 90 will be used for method development and 30 will be used as validation group. The latter will be used to evaluate how generalizable the results of the study are to the population, to avoid overestimating the model's capabilities in evaluating it on the same patients on which it was developed.
Key inclusion criteria (5 listed)
- Presence of one or more lesions classified as PI-RADSv2.1 ≥ 3 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
- Indication for eco-guided targeted biopsy by fusion technique integrated with systematic biopsy
- Indication for radical prostatectomy
- Participants aged 18 at the time of examination
- Obtaining informed consent.
Key exclusion criteria (2 listed)
- Impossibility of performing MRI (claustrophobic or obese participants etc.) or contraindications to the execution of MRI
- Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)
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
Distribution of ADC
Time frame: From enrollment to the end of treatment at 4 years
Evaluate the distribution of ADC values of the prostatic lesions cataloged according to the criteria PI-RADSv2.1 ≥ 3, comparing it with the distribution of ADC values of the healthy glandular tissue, to define a predictive threshold value for clinically significant neoplastic lesion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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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.
Caterina Gaudiano, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 (Adenocarcinoma), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 5 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: status not confirmed, as of the sponsor's last update on 14 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caterina Gaudiano, MD (+39 0515142307, caterina.gaudiano@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of ADC (time frame: From enrollment to the end of treatment at 4 years). 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 14 Jan 2025.