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

Prostate Cancer Clinical Trial

— CAPEMBOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407963
• Other study ID #: NIMAO/2017-01/JF-01
• Status: Completed
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: June 11, 2019

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 11, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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