Prostate CancerNCT04219059
MR Radiomic Features in Prostate Cancer
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 3 Sep 2019to 30 Mar 2021
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 200 male patients who have a pre-intervention prostate MRI with contrast agent from December 2015 to August 30, 2019 and biopsy proven Pca diagnosis, followed by radical prostatectomy will be evaluated.
Who may be able to join
- > 18 years of age
- In house MRI with contrast medium
- PCa (prostate cancer) biopsy proven diagnosis
- In house radical prostatectomy
Who cannot join
- < 18 years of age
- MRI without contrast medium
- Radical prostatectomy executed not in Institution
Trial locations and contacts
1 site in 1 country.
About this study
A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.
Read the detailed description
Quantitative approaches to medical image analysis have been developed in recent years with the aim to overcome the limitation of qualitative image interpretation, and provide biomarkers for disease characterization. In particular, the new paradigm, "radiomics", is emerging as the high-throughput extraction of quantitative features from imaging which can aid in characterizing phenotype as in vivo expression of tumoral genotype. The goal of radiomics is to extract accurate and reliable quantitative biomarkers which enhance diagnostic confidence in oncology. A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.
- Conditions
- Prostate Cancer
- Keywords
- cancer, prostate, radiomics, MRI, prognostic factors
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surrogate bioimaging markers of histological characteristics in MR images
Segment tumor volumes on the ADC map and extract different imaging features
Measured: 0-2 years
Secondary outcomes (2)
Radiomic features from MRI
Evaluate if radiomic features on primitive prostate lesions can describe lymph node involvement.
Measured: 0-2 years
Extract radiomic features
Evaluate if radiomic features fro MRIon primitive prostate lesions can describe disease extension.
Measured: 0-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start3 Sep 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- IBFM-CNR (Istituto di Bioimmagini e Fisiologia Molecolare, National Research Council, Segrate, Italy
- Responsible party
- Principal investigator, Francesco De Cobelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219059
- Sponsor's protocol ID
- ProTex
- Status last verified
- Sep 2026
- First submitted
- 25 Dec 2019
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Radiomic Features in Prostate Cancer
- ClinicalTrials.gov ID
- NCT04219059
- Acronym / sponsor ID
- ProTex
- Conditions
- Prostate Cancer
- Keywords
- cancer, prostate, radiomics, MRI, prognostic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- IBFM-CNR (Istituto di Bioimmagini e Fisiologia Molecolare, National Research Council, Segrate, Italy
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 6 Jan 2020 (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.
A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.
Detailed description
Quantitative approaches to medical image analysis have been developed in recent years with the aim to overcome the limitation of qualitative image interpretation, and provide biomarkers for disease characterization. In particular, the new paradigm, "radiomics", is emerging as the high-throughput extraction of quantitative features from imaging which can aid in characterizing phenotype as in vivo expression of tumoral genotype. The goal of radiomics is to extract accurate and reliable quantitative biomarkers which enhance diagnostic confidence in oncology. A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 male patients who have a pre-intervention prostate MRI with contrast agent from December 2015 to August 30, 2019 and biopsy proven Pca diagnosis, followed by radical prostatectomy will be evaluated.
Key inclusion criteria (4 listed)
- > 18 years of age
- In house MRI with contrast medium
- PCa (prostate cancer) biopsy proven diagnosis
- In house radical prostatectomy
Key exclusion criteria (3 listed)
- < 18 years of age
- MRI without contrast medium
- Radical prostatectomy executed not in Institution
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
Number of surrogate bioimaging markers of histological characteristics in MR images
Time frame: 0-2 years
Segment tumor volumes on the ADC map and extract different imaging features
2 secondary outcomes
Radiomic features from MRI
Time frame: 0-2 years
Extract radiomic features
Time frame: 0-2 years
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 Sep 2026.
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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?
An observational study of Prostate Cancer, run by IRCCS San Raffaele 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 4 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 Sep 2026. 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?
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?
Number of surrogate bioimaging markers of histological characteristics in MR images (time frame: 0-2 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 23 Sep 2026.