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

Centre Hospitalier Universitaire de Nīmes10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

EmbolizationPROCEDURE

Embolization by microparticles (300-500 microns)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Nimes

Nîmes, France

Outcomes

Primary Outcomes

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)

Time frame: Month 6

Presence of cancerous cells

Positive/negative according to biopsy of treated lobe

Time frame: Month 6

Secondary Outcomes

Global survival

days

Time frame: Month 6

Use of other mode of treatment

Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)

Time frame: Month 1

Use of other mode of treatment

Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)

Time frame: Month 3

Use of other mode of treatment

Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)

Time frame: Month 6

Necrosis of treated lobe