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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Embolization

• Registration Number: NCT03407963
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-23
• Study Start: 2018-06-26
• Primary Completion: 2019-06-11
• Study Completion: 2019-06-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate cancer patients	Embolization	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Use of other mode of treatment	Month 6	Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Necrosis of treated lobe	Month 6	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 6	ng/ml
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 6	International Prostate Symptom Score (IPSS score) (0-35)
Incontinence	Month 6	24-hr pad test (g)
Erectile dysfunction	Month 6	International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Health-related quality of life	Month 6	euroqol 5 dimension questionnaire (EQ-5D)
Global survival	Month 6	days

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France