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

Study Overview
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Brief Summary
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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

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate cancer patients<br> | Procedure: Embolization<br>* Embolization by microparticles (300-500 microns)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Month 6 | 
| Presence of cancerous cells | Positive/negative according to biopsy of treated lobe | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global survival | days | Month 6 | 
| Use of other mode of treatment | Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound) | Month 1 | 
| Use of other mode of treatment | Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound) | Month 3 | 
| Use of other mode of treatment | Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound) | Month 6 | 
| Necrosis of treated lobe | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Day 0 | 
| Necrosis of treated lobe | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Week 2 | 
| Necrosis of treated lobe | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Month 6 | 
| Change in size of target | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Day 0 | 
| Change in size of target | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Week 2 | 
| Change in size of target | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Month 6 | 
| Prostate specific antigen level | ng/ml | Month 1 | 
| Prostate specific antigen level | ng/ml | Month 3 | 
| Prostate specific antigen level | ng/ml | 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). | 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). | 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). | Month 6 | 
| Urinary symptoms | International Prostate Symptom Score (IPSS score) (0-35) | Month 1 | 
| Urinary symptoms | International Prostate Symptom Score (IPSS score) (0-35) | Month 3 | 
| Urinary symptoms | International Prostate Symptom Score (IPSS score) (0-35) | Month 6 | 
| Incontinence | 24-hr pad test (g) | Month 1 | 
| Incontinence | 24-hr pad test (g) | Month 3 | 
| Incontinence | 24-hr pad test (g) | Month 6 | 
| Erectile dysfunction | International Index of Erectile Function (IIEF-6) questionnaire (score 0-30) | Month 1 | 
| Erectile dysfunction | International Index of Erectile Function (IIEF-6) questionnaire (score 0-30) | Month 3 | 
| Erectile dysfunction | International Index of Erectile Function (IIEF-6) questionnaire (score 0-30) | Month 6 | 
| Health-related quality of life | euroqol 5 dimension questionnaire (EQ-5D) | Month 1 | 
| Health-related quality of life | euroqol 5 dimension questionnaire (EQ-5D) | Month 3 | 
| Health-related quality of life | euroqol 5 dimension questionnaire (EQ-5D) | Month 6 |