Clinical trial NCT03407963: Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Official title: Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Complications arising from embolization
timeFrame: Month 6
measure: Presence of cancerous cells
timeFrame: Month 6
Secondary outcomes:
measure: Global survival
timeFrame: Month 6
measure: Use of other mode of treatment
timeFrame: Month 1
measure: Use of other mode of treatment
timeFrame: Month 3
measure: Use of other mode of treatment
timeFrame: Month 6
measure: Necrosis of treated lobe
timeFrame: Day 0
measure: Necrosis of treated lobe
timeFrame: Week 2
measure: Necrosis of treated lobe
timeFrame: Month 6
measure: Change in size of target
timeFrame: Day 0
measure: Change in size of target
timeFrame: Week 2
measure: Change in size of target
timeFrame: Month 6
measure: Prostate specific antigen level
timeFrame: Month 1
measure: Prostate specific antigen level
timeFrame: Month 3
measure: Prostate specific antigen level
timeFrame: Month 6
measure: Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
timeFrame: Month 1
measure: Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
timeFrame: Month 3
measure: Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
timeFrame: Month 6
measure: Urinary symptoms
timeFrame: Month 1
measure: Urinary symptoms
timeFrame: Month 3
measure: Urinary symptoms
timeFrame: Month 6
measure: Incontinence
timeFrame: Month 1
measure: Incontinence
timeFrame: Month 3
measure: Incontinence
timeFrame: Month 6
measure: Erectile dysfunction
timeFrame: Month 1
measure: Erectile dysfunction
timeFrame: Month 3
measure: Erectile dysfunction
timeFrame: Month 6
measure: Health-related quality of life
timeFrame: Month 1
measure: Health-related quality of life
timeFrame: Month 3
measure: Health-related quality of life
timeFrame: Month 6
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Julian Frandon, MD
role: STUDY_DIRECTOR
References: