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

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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Embolization

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostate cancer patients	Procedure: Embolization; Embolization by microparticles (300-500 microns)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Julian Frandon, MD, CHU Nimes

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): June 11, 2019
• Study Completion (Actual): June 11, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NIMAO/2017-01/JF-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No