Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study (CAPEMBOL)

November 26, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
The authors hypothesize that, in patients with low volume tumors identified according to anatomo-pathological criteria and imaging, and under active surveillance focal, therapy by unilateral embolization of prostatic arteries will provide local control of the tumor via selective ischemia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU Nimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is between 18 and 80 years old
  • Patient has unilateral prostate cancer, stage TNM<T2b with an MRI PiRAds target ≥ 3 in concordance with biopsy result
  • Biopsy gives a Gleason score ≤ 6 with more than 3 positive biopsies per lob and at least 50% the length of the positive biopsy; patients over 70 years old with a Gleason score = 7 (3+4) can be included
  • Patient has a life expectancy of over 10 years
  • PSA <10ng/ml; patients with a large prostatic volume and PSA ≥ 10ng/ml can be included according to doctor discretion.

Exclusion Criteria:

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient unresponsive to active surveillance
  • Patient refusing active surveillance
  • Patients in a state unfit to express personal consent cannot be solicited (eg patients undergoing psychiatric treatment with mental difficulties rendering consent impossible)
  • Contraindication for MRI (pacemaker incompatible with MRI, claustrophobia, metal device, prosthetic hip replacement)
  • Patient with hemostasis disorder.
  • Cancer in both prostate lobes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prostate cancer patients
Procedure: Embolization
Embolization by microparticles (300-500 microns)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complications arising from embolization
Time Frame: Month 6
Presence/absence of complications beyond those expected linked to embolization (persistent urinary infection, dysuria, rectorrhagia, hematuria, hemospermia, acute urinary retention and pelvic perineal pain)
Month 6
Presence of cancerous cells
Time Frame: Month 6
Positive/negative according to biopsy of treated lobe
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global survival
Time Frame: Month 6
days
Month 6
Use of other mode of treatment
Time Frame: Month 1
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Month 1
Use of other mode of treatment
Time Frame: Month 3
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Month 3
Use of other mode of treatment
Time Frame: Month 6
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Month 6
Necrosis of treated lobe
Time Frame: Day 0
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Day 0
Necrosis of treated lobe
Time Frame: Week 2
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Week 2
Necrosis of treated lobe
Time Frame: Month 6
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Month 6
Change in size of target
Time Frame: Day 0
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Day 0
Change in size of target
Time Frame: Week 2
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Week 2
Change in size of target
Time Frame: Month 6
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Month 6
Prostate specific antigen level
Time Frame: Month 1
ng/ml
Month 1
Prostate specific antigen level
Time Frame: Month 3
ng/ml
Month 3
Prostate specific antigen level
Time Frame: Month 6
ng/ml
Month 6
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Time Frame: Month 1
Expected events: severe allergic reaction to contrast product, septicemia with urinary origin, persistent urinary infection, dysuria, serious hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectorrhagia, irradiation-induced severe epidermal lesions, acute urinary retention, pelvic-perineal pain, prostatitis, epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder, elevation of PSA (at 6 months linked to probable disease progression).
Month 1
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Time Frame: Month 3
Expected events: severe allergic reaction to contrast product, septicemia with urinary origin, persistent urinary infection, dysuria, serious hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectorrhagia, irradiation-induced severe epidermal lesions, acute urinary retention, pelvic-perineal pain, prostatitis, epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder, elevation of PSA (at 6 months linked to probable disease progression).
Month 3
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Time Frame: Month 6
Expected events: severe allergic reaction to contrast product, septicemia with urinary origin, persistent urinary infection, dysuria, serious hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectorrhagia, irradiation-induced severe epidermal lesions, acute urinary retention, pelvic-perineal pain, prostatitis, epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder, elevation of PSA (at 6 months linked to probable disease progression).
Month 6
Urinary symptoms
Time Frame: Month 1
International Prostate Symptom Score (IPSS score) (0-35)
Month 1
Urinary symptoms
Time Frame: Month 3
International Prostate Symptom Score (IPSS score) (0-35)
Month 3
Urinary symptoms
Time Frame: Month 6
International Prostate Symptom Score (IPSS score) (0-35)
Month 6
Incontinence
Time Frame: Month 1
24-hr pad test (g)
Month 1
Incontinence
Time Frame: Month 3
24-hr pad test (g)
Month 3
Incontinence
Time Frame: Month 6
24-hr pad test (g)
Month 6
Erectile dysfunction
Time Frame: Month 1
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Month 1
Erectile dysfunction
Time Frame: Month 3
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Month 3
Erectile dysfunction
Time Frame: Month 6
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Month 6
Health-related quality of life
Time Frame: Month 1
euroqol 5 dimension questionnaire (EQ-5D)
Month 1
Health-related quality of life
Time Frame: Month 3
euroqol 5 dimension questionnaire (EQ-5D)
Month 3
Health-related quality of life
Time Frame: Month 6
euroqol 5 dimension questionnaire (EQ-5D)
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Julian Frandon, MD, CHU Nimes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2017-01/JF-01
  • 2017-A01915-48 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Dietary Supplements

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