Prostatic AdenocarcinomaPREBOPNCT04063800
Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI
An observational study of Prostatic Adenocarcinoma, run by University Hospital, Brest at 2 sites in France.
Trial summary
With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management. Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Adenocarcinoma
- How many people
- 195 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Jun 2018to 28 Aug 2018
- 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
- Adult, Older adult
Study population: - Patients with high-risk prostate cancers who underwent pre-operative prostate MRI followed by radical prostatectomy +/- lymphadenectomy
Who may be able to join
- Age > 18yo
- Patients underwent radical prostatectomy
- High-risk prostate cancers: at least 1 criteria (pt3a/pT3b/pT4, R1, Gleason score > 7)
Who cannot join
- No available pre-operative MRI
- No analyzable pre-operative MRI
- proof of lymph-node involvement (cN1/2 or pN1/2)
- post-operative PSA > 0.04ng/mL
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Brest
Brest, Brittany Region, 29609
Centre Hospitalier de Cornouaille
Quimper, Brittany Region, 29000
About this study
With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.
Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.
We aim to build and test three predictive models (clinical, radiomic and combined models).
- Conditions
- Prostatic Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of biochemical failure
Comparison of AUCs between each predictive model
Measured: From the date of surgery until data collection (up to 100 months)
Secondary outcomes (1)
Prediction of survival without biochemical failure
Survival analysis: comparison of Kaplan-Meier curves
Measured: From the date of surgery until data collection (up to 100 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start26 Jun 2018
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic AdenocarcinomaStudies 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063800
- Sponsor's protocol ID
- PREBOP (29BRC18.0108)
- Acronym
- PREBOP
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 12 Sep 2019
- 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 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI
- ClinicalTrials.gov ID
- NCT04063800
- Acronym / sponsor ID
- PREBOP / PREBOP (29BRC18.0108)
- Conditions
- Prostatic Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 21 Aug 2019 (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.
With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.
Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.
We aim to build and test three predictive models (clinical, radiomic and combined models).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- - Patients with high-risk prostate cancers who underwent pre-operative prostate MRI followed by radical prostatectomy +/- lymphadenectomy
Key inclusion criteria (3 listed)
- Age > 18yo
- Patients underwent radical prostatectomy
- High-risk prostate cancers: at least 1 criteria (pt3a/pT3b/pT4, R1, Gleason score > 7)
Key exclusion criteria (4 listed)
- No available pre-operative MRI
- No analyzable pre-operative MRI
- proof of lymph-node involvement (cN1/2 or pN1/2)
- post-operative PSA > 0.04ng/mL
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
Prediction of biochemical failure
Time frame: From the date of surgery until data collection (up to 100 months)
Comparison of AUCs between each predictive model
1 secondary outcome
Prediction of survival without biochemical failure
Time frame: From the date of surgery until data collection (up to 100 months)
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 12 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Adenocarcinoma, run by University Hospital, Brest at 2 sites 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 3 inclusion and 4 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 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Prediction of biochemical failure (time frame: From the date of surgery until data collection (up to 100 months)). 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 12 Sep 2019.