Prostate Cancer
Conditions
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
Interventions
PROCEDUREEmbolization
Embolization by microparticles (300-500 microns)
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications arising from embolization | 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 | Month 6 | Positive/negative according to biopsy of treated lobe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Necrosis of treated lobe | Day 0 | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion \>10mm) |
| Change in size of target | Day 0 | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion \>10mm) |
| Prostate specific antigen level | Month 1 | ng/ml |
| Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification | 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). |
| Global survival | Month 6 | days |
| Incontinence | Month 1 | 24-hr pad test (g) |
| Erectile dysfunction | Month 1 | International Index of Erectile Function (IIEF-6) questionnaire (score 0-30) |
| Health-related quality of life | Month 1 | euroqol 5 dimension questionnaire (EQ-5D) |
| Urinary symptoms | Month 1 | International Prostate Symptom Score (IPSS score) (0-35) |
| Use of other mode of treatment | Month 1 | Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound) |
Countries
France
Outcome results
None listed