Prostate CancerEMBOPERFNCT05389202
Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma
A study testing Perfusion CT scanning in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of better selecting patients to avoid this long procedure in non-responders. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Perfusion CT scanning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2022to 19 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients with symptomatic benign prostatic hypertrophy (prostate volume > 50, IPSS >7, QoL>2) or patients catheterized after acute retention of urine with failed catheterization.
- Creatinine clearance > 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
- Adult patients (≥18 years).
- Patients with an indication for prostate embolization.
- Patient with free and informed consent.
- Patient who have signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
Who cannot join
- Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
- Severe renal impairment with renal function <30mL/min.
- Contraindication to prostate embolization (aorto-iliac bypass)
- Patient participating in research defined as Category 1 Research Involving Human Subjects.
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma. A Single-center Prospective Cohort Pilot Study to Determine the Predictive Factors of Clinical Efficacy Associated With a Prior Phantom Study.
Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of better selecting patients to avoid this long procedure in non-responders. The hypothesis is that prostate perfusion parameters are correlated with the efficacy of embolization. Studying these prostate perfusion parameters in perfusion CT and evaluating prostate Iodine load in dual energy computed tomography will make it easier to select those patients who are most likely to respond.
Read the detailed description
The hypothesis is that there are two types of prostate vascularization in patients with symptomatic prostate adenoma:
- prostates mainly vascularized by large caliber prostate arteries with high flow, for which perfusion parameters in favor of hyper-perfusion will be found. In this case, prostate artery embolization will be effective;
- prostates vascularized by a network of collaterals, with low flow-rates, for which perfusion parameters in favor of hypo-perfusion will be found. In this case, prostate artery embolization will not be very effective.
The purpose of this study is to investigate the association between prostate perfusion parameters (peak time, transit time, blood volume, capillary permeability) and the clinical efficacy of prostate embolization at 3 months. These perfusion parameters could become new biomarkers leading to better selection of patients eligible for efficient prostate embolization, in order to avoid a considerable treatment with no benefit for certain patients and thus limit their global exposure to X-rays during care.
Prior to this prospective study on patients with symptomatic benign prostate hypertrophy, a preliminary experimental study will be performed on a perfusion phantom in order to better understand the differences in the calculation of perfusion parameters according to the three main algorithms used. This will lead to optimization of the prostate perfusion protocol for the scanner: computed tomography acquisition parameters (kilovoltage, Milliamps per second) and therefore the X-ray dose delivered to patients, sampling frequency, and model to be used. The first results of this study have already led to modifications in scanner perfusion acquisition protocols for the initiation of clinical study.
- Conditions
- Prostate Cancer
- Being tested
- Perfusion CT scanning
- Keywords
- Prostate, Adenoma, Embolization
- Medical subject headings
- Prostatic Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion CT scanningOther
Abdominopelvic CT scan with perfusion and spectral analysis performed 7 days (± 5 days) before prostate embolization.
| Study group | Role | What they receive |
|---|---|---|
| Patients benefitting from a perfusion CT scan before embolization | Experimental | Prostatic perfusion parameters seem to be correlated with the effectiveness of embolization. Studying these prostatic perfusion parameters in perfusion CT and evaluating the prostatic Iodine load in dual energy CT will make it possible to better select responder patients. Receives: Other: Perfusion CT scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheterized patients: Removal of the urinary catheter at 3 months
Yes/No
Measured: Month 3
Non-catheterized patients: 25% decrease in the International Prostate Symptom Score
Yes/No
Measured: Month 3
Non-catheterized patients: one point improvement in the Global Quality of Life Score.
Yes/No
Measured: Month 3
MRI perfusion parameters : Capillary permeability
Measured in mL.mL tissue-1.min-1
Measured: 7 - 14 days before embolization
Scanner perfusion parameters : Capillary permeability
Measured in mL.mL tissue-1.min-1
Measured: Day 0 (on the day of embolization)
MRI perfusion parameters : Extracellular volume
Measured in mL.mL tissue-1
Measured: 7 - 14 days before embolization
Scanner perfusion parameters : Extracellular volume
Measured in mL.mL tissue-1
Measured: Day 0 (on the day of embolization)
MRI perfusion parameters : Blood volume
Measured in mL.mL tissue-1
Measured: 7 - 14 days before embolization
Scanner perfusion parameters : Blood volume
Measured in mL.mL tissue-1
Measured: Day 0 (on the day of embolization)
MRI perfusion parameters : Maximum slope
Measured in ml.min-1
Measured: 7 - 14 days before embolization
Scanner perfusion parameters : Maximum slope
Measured in ml.min-1
Measured: Day 0 (on the day of embolization)
MRI perfusion parameters : Time to peak
Measured in seconds
Measured: 7 - 14 days before embolization
MRI perfusion parameters : Time to peak
Measured in seconds
Measured: Day 0 (on the day of embolization)
Scanner perfusion parameters : Prostate iodine load at 80 s.
Measured in mgI.mg of prostate-1
Measured: 7 - 14 days before embolization
MRI perfusion parameters : Prostate iodine load at 80 s.
Measured in mgI.mg of prostate-1
Measured: Day 0 (on the day of embolization)
Secondary outcomes (15)
Influence of flow rate on the scanner algorithm
The influence of flow rate on the scanner algorithm will be measured on the perfusion phantom model in mL.min-1.
Measured: 1 - 15 days before embolization. Preliminary stage on phantom.
A. Correspondence between MRI and scanner: Capillary permeability
Measured in mL.mL tissue-1.min-1
Measured: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Extracellular volume
Measured in mL.mL tissue-1
Measured: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Blood volume
Measured in mL.mL tissue-1
Measured: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Maximum slope
Measured in mL.min-1
Measured: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Time to peak
Measured in seconds
Measured: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: 80-second iodine load
Measured in mgl.mg of prostate-1
Measured: 1 - 7 days before embolization
B. 4-D map Magnetic Resonance Imaging perfusion parameters : Volume of beads injected
Measured in mL
Measured: At the time of embolization
B. Scanner perfusion parameters : Volume of beads injected
Measured in mL
Measured: At the time of embolization
C. Influence of scanner acquisition parameters: kV
The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.
Measured: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Influence of scanner acquisition parameters: mAs
The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.
Measured: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Influence of scanner acquisition parameters: iterative reconstruction
The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.
Measured: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Blood volume
The perfusion parameter "blood volume" will be measured on the phantom in mL
Measured: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Maximum slope
The perfusion parameter "maximum slope" will be measured on the phantom in mL.min-1
Measured: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Time to peak
The perfusion parameter "time to peak" will be measured on the phantom in seconds
Measured: 1 to 15 days before embolization. Preliminary stage on phantom.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start12 May 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389202
- Sponsor's protocol ID
- NIMAO/2021-1/JF-01
- Acronym
- EMBOPERF
- Status last verified
- Mar 2025
- First submitted
- 11 May 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma. A Single-center Prospective Cohort Pilot Study to Determine the Predictive Factors of Clinical Efficacy Associated With a Prior Phantom Study.
- ClinicalTrials.gov ID
- NCT05389202
- Acronym / sponsor ID
- EMBOPERF / NIMAO/2021-1/JF-01
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Adenoma, Embolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 25 May 2022 (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.
Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of better selecting patients to avoid this long procedure in non-responders. The hypothesis is that prostate perfusion parameters are correlated with the efficacy of embolization. Studying these prostate perfusion parameters in perfusion CT and evaluating prostate Iodine load in dual energy computed tomography will make it easier to select those patients who are most likely to respond.
Detailed description
The hypothesis is that there are two types of prostate vascularization in patients with symptomatic prostate adenoma:
- prostates mainly vascularized by large caliber prostate arteries with high flow, for which perfusion parameters in favor of hyper-perfusion will be found. In this case, prostate artery embolization will be effective;
- prostates vascularized by a network of collaterals, with low flow-rates, for which perfusion parameters in favor of hypo-perfusion will be found. In this case, prostate artery embolization will not be very effective.
The purpose of this study is to investigate the association between prostate perfusion parameters (peak time, transit time, blood volume, capillary permeability) and the clinical efficacy of prostate embolization at 3 months. These perfusion parameters could become new biomarkers leading to better selection of patients eligible for efficient prostate embolization, in order to avoid a considerable treatment with no benefit for certain patients and thus limit their global exposure to X-rays during care.
Prior to this prospective study on patients with symptomatic benign prostate hypertrophy, a preliminary experimental study will be performed on a perfusion phantom in order to better understand the differences in the calculation of perfusion parameters according to the three main algorithms used. This will lead to optimization of the prostate perfusion protocol for the scanner: computed tomography acquisition parameters (kilovoltage, Milliamps per second) and therefore the X-ray dose delivered to patients, sampling frequency, and model to be used. The first results of this study have already led to modifications in scanner perfusion acquisition protocols for the initiation of clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients benefitting from a perfusion CT scan before embolization | Experimental | Other: Perfusion CT scanningProstatic perfusion parameters seem to be correlated with the effectiveness of embolization. Studying these prostatic perfusion parameters in perfusion CT and evaluating the prostatic Iodine load in dual energy CT will make it possible to better select responder patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with symptomatic benign prostatic hypertrophy (prostate volume > 50, IPSS >7, QoL>2) or patients catheterized after acute retention of urine with failed catheterization.
- Creatinine clearance > 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
- Adult patients (≥18 years).
- Patients with an indication for prostate embolization.
- Patient with free and informed consent.
Key exclusion criteria (8 listed)
- Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
- Severe renal impairment with renal function <30mL/min.
- Contraindication to prostate embolization (aorto-iliac bypass)
- Patient participating in research defined as Category 1 Research Involving Human Subjects.
- Patient in an exclusion period as determined by another study.
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 |
|---|---|---|
| Perfusion CT scanningAbdominopelvic CT scan with perfusion and spectral analysis performed 7 days (± 5 days) before prostate embolization. | Other | Patients benefitting from a perfusion CT scan before embolization |
Primary outcome
Catheterized patients: Removal of the urinary catheter at 3 months
Time frame: Month 3
Yes/No
Non-catheterized patients: 25% decrease in the International Prostate Symptom Score
Time frame: Month 3
Yes/No
Non-catheterized patients: one point improvement in the Global Quality of Life Score.
Time frame: Month 3
Yes/No
MRI perfusion parameters : Capillary permeability
Time frame: 7 - 14 days before embolization
Measured in mL.mL tissue-1.min-1
Scanner perfusion parameters : Capillary permeability
Time frame: Day 0 (on the day of embolization)
Measured in mL.mL tissue-1.min-1
MRI perfusion parameters : Extracellular volume
Time frame: 7 - 14 days before embolization
Measured in mL.mL tissue-1
Scanner perfusion parameters : Extracellular volume
Time frame: Day 0 (on the day of embolization)
Measured in mL.mL tissue-1
MRI perfusion parameters : Blood volume
Time frame: 7 - 14 days before embolization
Measured in mL.mL tissue-1
Scanner perfusion parameters : Blood volume
Time frame: Day 0 (on the day of embolization)
Measured in mL.mL tissue-1
MRI perfusion parameters : Maximum slope
Time frame: 7 - 14 days before embolization
Measured in ml.min-1
Scanner perfusion parameters : Maximum slope
Time frame: Day 0 (on the day of embolization)
Measured in ml.min-1
MRI perfusion parameters : Time to peak
Time frame: 7 - 14 days before embolization
Measured in seconds
MRI perfusion parameters : Time to peak
Time frame: Day 0 (on the day of embolization)
Measured in seconds
Scanner perfusion parameters : Prostate iodine load at 80 s.
Time frame: 7 - 14 days before embolization
Measured in mgI.mg of prostate-1
MRI perfusion parameters : Prostate iodine load at 80 s.
Time frame: Day 0 (on the day of embolization)
Measured in mgI.mg of prostate-1
15 secondary outcomes
Influence of flow rate on the scanner algorithm
Time frame: 1 - 15 days before embolization. Preliminary stage on phantom.
A. Correspondence between MRI and scanner: Capillary permeability
Time frame: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Extracellular volume
Time frame: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Blood volume
Time frame: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Maximum slope
Time frame: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: Time to peak
Time frame: 1 - 7 days before embolization
A. Correspondence between MRI and scanner: 80-second iodine load
Time frame: 1 - 7 days before embolization
B. 4-D map Magnetic Resonance Imaging perfusion parameters : Volume of beads injected
Time frame: At the time of embolization
B. Scanner perfusion parameters : Volume of beads injected
Time frame: At the time of embolization
C. Influence of scanner acquisition parameters: kV
Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Influence of scanner acquisition parameters: mAs
Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Influence of scanner acquisition parameters: iterative reconstruction
Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Blood volume
Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Maximum slope
Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.
C. Time to peak
Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.
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 10 Mar 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.
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?
A study testing Perfusion CT scanning in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes 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 7 inclusion and 8 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 10 Mar 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 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?
Catheterized patients: Removal of the urinary catheter at 3 months (time frame: Month 3). The study lists 15 primary outcomes in all. 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 10 Mar 2025.