Prostate CancerCAPEMBOLNCT03407963
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
A study testing Embolization in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2018to 3 Nov 2020
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Prostate Cancer
- Being tested
- Embolization
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolizationProcedure or surgery
Embolization by microparticles (300-500 microns)
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer patients | Experimental | Not described Receives: Procedure: Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications arising from embolization
Presence/absence of complications beyond those expected linked to embolization (persistent urinary infection, dysuria, rectorrhagia, hematuria, hemospermia, acute urinary retention and pelvic perineal pain)
Measured: Month 6
Presence of cancerous cells
Positive/negative according to biopsy of treated lobe
Measured: Month 6
Secondary outcomes (28)
Global survival
days
Measured: Month 6
Use of other mode of treatment
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Measured: Month 1
Use of other mode of treatment
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Measured: Month 3
Use of other mode of treatment
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Measured: Month 6
Necrosis of treated lobe
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Measured: Day 0
Necrosis of treated lobe
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Measured: Week 2
Necrosis of treated lobe
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Measured: Month 6
Change in size of target
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Measured: Day 0
Change in size of target
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Measured: Week 2
Change in size of target
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Measured: Month 6
Prostate specific antigen level
ng/ml
Measured: Month 1
Prostate specific antigen level
ng/ml
Measured: Month 3
Prostate specific antigen level
ng/ml
Measured: Month 6
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
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).
Measured: Month 1
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
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).
Measured: Month 3
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
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).
Measured: Month 6
Urinary symptoms
International Prostate Symptom Score (IPSS score) (0-35)
Measured: Month 1
Urinary symptoms
International Prostate Symptom Score (IPSS score) (0-35)
Measured: Month 3
Urinary symptoms
International Prostate Symptom Score (IPSS score) (0-35)
Measured: Month 6
Incontinence
24-hr pad test (g)
Measured: Month 1
Incontinence
24-hr pad test (g)
Measured: Month 3
Incontinence
24-hr pad test (g)
Measured: Month 6
Erectile dysfunction
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Measured: Month 1
Erectile dysfunction
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Measured: Month 3
Erectile dysfunction
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Measured: Month 6
Health-related quality of life
euroqol 5 dimension questionnaire (EQ-5D)
Measured: Month 1
Health-related quality of life
euroqol 5 dimension questionnaire (EQ-5D)
Measured: Month 3
Health-related quality of life
euroqol 5 dimension questionnaire (EQ-5D)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start26 Jun 2018
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Frandon, MD, Study director, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407963
- Sponsor's protocol ID
- NIMAO/2017-01/JF-01
- Other IDs
- 2017-A01915-48
- Acronym
- CAPEMBOL
- Status last verified
- Jun 2020
- First submitted
- 9 Jan 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frandon J, Bey E, Hamard A, Mohammad H, Gonzalez S, Greffier J, Chevallier T, de Forges H, Beregi JP, Droupy S. Early Results of Unilateral Prostatic Artery Embolization as a Focal Therapy in Patients with Prostate Cancer under Active Surveillance: Cancer Prostate Embolisation, a Pilot Study. J Vasc Interv Radiol. 2021 Feb;32(2):247-255. doi: 10.1016/j.jvir.2020.10.002. Epub 2020 Nov 25.
PubMed 33248919
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
- ClinicalTrials.gov ID
- NCT03407963
- Acronym / sponsor ID
- CAPEMBOL / NIMAO/2017-01/JF-01
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 23 Jan 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patients | Experimental | Procedure: Embolization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| EmbolizationEmbolization by microparticles (300-500 microns) | Procedure or surgery | Prostate cancer patients |
Primary outcome
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)
Presence of cancerous cells
Time frame: Month 6
Positive/negative according to biopsy of treated lobe
28 secondary outcomes
Global survival
Time frame: Month 6
Use of other mode of treatment
Time frame: Month 1
Use of other mode of treatment
Time frame: Month 3
Use of other mode of treatment
Time frame: Month 6
Necrosis of treated lobe
Time frame: Day 0
Necrosis of treated lobe
Time frame: Week 2
Necrosis of treated lobe
Time frame: Month 6
Change in size of target
Time frame: Day 0
Change in size of target
Time frame: Week 2
Change in size of target
Time frame: Month 6
Prostate specific antigen level
Time frame: Month 1
Prostate specific antigen level
Time frame: Month 3
Prostate specific antigen level
Time frame: Month 6
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Time frame: Month 1
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Time frame: Month 3
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Time frame: Month 6
Urinary symptoms
Time frame: Month 1
Urinary symptoms
Time frame: Month 3
Urinary symptoms
Time frame: Month 6
Incontinence
Time frame: Month 1
Incontinence
Time frame: Month 3
Incontinence
Time frame: Month 6
Erectile dysfunction
Time frame: Month 1
Erectile dysfunction
Time frame: Month 3
Erectile dysfunction
Time frame: Month 6
Health-related quality of life
Time frame: Month 1
Health-related quality of life
Time frame: Month 3
Health-related quality of life
Time frame: Month 6
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 4 Dec 2025.
- Results publication: PubMed 33248919Frandon J, Bey E, Hamard A, Mohammad H, Gonzalez S, Greffier J, Chevallier T, de Forges H, Beregi JP, Droupy S. Early Results of Unilateral Prostatic Artery Embolization as a Focal Therapy in Patients with Prostate Cancer under Active Surveillance: Cancer Prostate Embolisation, a Pilot Study. J Vasc Interv Radiol. 2021 Feb;32(2):247-255. doi: 10.1016/j.jvir.2020.10.002. Epub 2020 Nov 25.
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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.
Julian Frandon, MD study director
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization 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 10 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 4 Dec 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?
Complications arising from embolization (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407963, which also lists 1 linked publication.
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 4 Dec 2025.