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

• Embolization (Procedure): Embolization by microparticles (300-500 microns)

Primary outcomes

• 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 outcomes

• Global survival [Month 6]: days
• Use of other mode of treatment [Month 1]: Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
• Use of other mode of treatment [Month 3]: Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
• Use of other mode of treatment [Month 6]: Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
• Necrosis of treated lobe [Day 0]: MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
• Necrosis of treated lobe [Week 2]: MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
• Necrosis of treated lobe [Month 6]: 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)
• Change in size of target [Week 2]: MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
• Change in size of target [Month 6]: MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
• Prostate specific antigen level [Month 1]: ng/ml
• Prostate specific antigen level [Month 3]: ng/ml
• Prostate specific antigen level [Month 6]: 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).
• Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification [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).
• Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification [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).
• Urinary symptoms [Month 1]: International Prostate Symptom Score (IPSS score) (0-35)
• Urinary symptoms [Month 3]: International Prostate Symptom Score (IPSS score) (0-35)
• Urinary symptoms [Month 6]: International Prostate Symptom Score (IPSS score) (0-35)
• Incontinence [Month 1]: 24-hr pad test (g)
• Incontinence [Month 3]: 24-hr pad test (g)
• Incontinence [Month 6]: 24-hr pad test (g)
• Erectile dysfunction [Month 1]: International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
• Erectile dysfunction [Month 3]: International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
• Erectile dysfunction [Month 6]: International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
• Health-related quality of life [Month 1]: euroqol 5 dimension questionnaire (EQ-5D)
• Health-related quality of life [Month 3]: euroqol 5 dimension questionnaire (EQ-5D)
• Health-related quality of life [Month 6]: euroqol 5 dimension questionnaire (EQ-5D)

Sex: Male, ages: 18 Years to 80 Years

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

• Results publication: 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. PMID 33248919

• Julian Frandon, MD, Study director, CHU Nimes