Adenocarcinoma of the ProstatePRED-NCHIRNCT04909957
Prediction of Lymph Node Invasion for Prostate Adenocarcinoma
An observational study of Adenocarcinoma of the Prostate, run by University Hospital, Brest at 1 site in France.
Trial summary
Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Nov 2022
- 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: The population consists of patients operated on for an adenocarcinoma of the prostate by radical prostatectomy with extensive lymph node dissection and for whom pre-operative MRI is available and analyzable.
Who may be able to join
- Histologically proven adenocarcinoma of the prostate treated by prostatectomy with extensive lymph node dissection
- Available pre-operative +/- PET choline
Who cannot join
- Unanalyzable pre-operative MRI
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Brest
Brest, 29200
Ulrike Schick, MD, PhD, +33298223398, ulrike.schick@chu-brest.fr
About this study
Official title: Prediction of Lymph Node Invasion in Patients Operated on for Prostate Adenocarcinoma
Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Significant advances in LNI risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (MRI) data, but it is likely that quantitative analysis could further improve prediction models. In this study, the investigators aimed to develop and internally validate a novel LNI risk prediction model based on radiomic features extracted from pre-operative multimodal MRI.
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- MRI, Lymph node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Absence of invaded lymph node after extensive lymph node dissection | Absence of invaded lymph node after extensive lymph node dissection | |
| Presence of invaded lymph node after extensive lymph node dissection | Presence of invaded lymph node after extensive lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicted risk of lymph-node involvement vs Briganti 2017
Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2017
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (5)
Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC
Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC
Measured: immediately after the intervention/procedure/surgery
Biochemical recurrence free survival
Prediction of Biochemical recurrence free survival
Measured: immediately after the intervention/procedure/surgery
Extra-prostatic disease
Prediction of Extra-prostatic disease
Measured: immediately after the intervention/procedure/surgery
Seminal vesicle invasion
Prediction of Seminal vesicle invasion
Measured: immediately after the intervention/procedure/surgery
Automatic segmentation of the index lesion
Comparison between a manual segmentation of the index lesion and an automatic segmentation
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Jan 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909957
- Sponsor's protocol ID
- 29BRC20.0290
- Acronym
- PRED-NCHIR
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Lymph Node Invasion in Patients Operated on for Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04909957
- Acronym / sponsor ID
- PRED-NCHIR / 29BRC20.0290
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- MRI, Lymph node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 2 Jun 2021 (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.
Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Significant advances in LNI risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (MRI) data, but it is likely that quantitative analysis could further improve prediction models. In this study, the investigators aimed to develop and internally validate a novel LNI risk prediction model based on radiomic features extracted from pre-operative multimodal MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absence of invaded lymph node after extensive lymph node dissection | – | –Absence of invaded lymph node after extensive lymph node dissection |
| Presence of invaded lymph node after extensive lymph node dissection | – | –Presence of invaded lymph node after extensive lymph node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of patients operated on for an adenocarcinoma of the prostate by radical prostatectomy with extensive lymph node dissection and for whom pre-operative MRI is available and analyzable.
Key inclusion criteria (2 listed)
- Histologically proven adenocarcinoma of the prostate treated by prostatectomy with extensive lymph node dissection
- Available pre-operative +/- PET choline
Key exclusion criteria (1 listed)
- Unanalyzable pre-operative MRI
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
Predicted risk of lymph-node involvement vs Briganti 2017
Time frame: immediately after the intervention/procedure/surgery
Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2017
5 secondary outcomes
Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC
Time frame: immediately after the intervention/procedure/surgery
Biochemical recurrence free survival
Time frame: immediately after the intervention/procedure/surgery
Extra-prostatic disease
Time frame: immediately after the intervention/procedure/surgery
Seminal vesicle invasion
Time frame: immediately after the intervention/procedure/surgery
Automatic segmentation of the index lesion
Time frame: immediately after the intervention/procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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 Adenocarcinoma of the Prostate, run by University Hospital, Brest at 1 site in France.
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 1 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 19 Jan 2022. 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 France. 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 Ulrike Ulrike Schick (+33298223398, ulrike.schick@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicted risk of lymph-node involvement vs Briganti 2017 (time frame: immediately after the intervention/procedure/surgery). 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 19 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.