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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Embolization
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Nimes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate cancer patients

Arm Description

Outcomes

Primary Outcome Measures

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)
Presence of cancerous cells
Positive/negative according to biopsy of treated lobe

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2018
Last Updated
July 7, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03407963
Brief Title
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Acronym
CAPEMBOL
Official Title
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
June 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate cancer patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Embolization
Intervention Description
Embolization by microparticles (300-500 microns)
Primary Outcome Measure Information:
Title
Complications arising from embolization
Description
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
Title
Presence of cancerous cells
Description
Positive/negative according to biopsy of treated lobe
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Global survival
Description
days
Time Frame
Month 6
Title
Use of other mode of treatment
Description
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Time Frame
Month 1
Title
Use of other mode of treatment
Description
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Time Frame
Month 3
Title
Use of other mode of treatment
Description
Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)
Time Frame
Month 6
Title
Necrosis of treated lobe
Description
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Time Frame
Day 0
Title
Necrosis of treated lobe
Description
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Time Frame
Week 2
Title
Necrosis of treated lobe
Description
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Time Frame
Month 6
Title
Change in size of target
Description
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Time Frame
Day 0
Title
Change in size of target
Description
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Time Frame
Week 2
Title
Change in size of target
Description
MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)
Time Frame
Month 6
Title
Prostate specific antigen level
Description
ng/ml
Time Frame
Month 1
Title
Prostate specific antigen level
Description
ng/ml
Time Frame
Month 3
Title
Prostate specific antigen level
Description
ng/ml
Time Frame
Month 6
Title
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Description
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).
Time Frame
Month 1
Title
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Description
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).
Time Frame
Month 3
Title
Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification
Description
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).
Time Frame
Month 6
Title
Urinary symptoms
Description
International Prostate Symptom Score (IPSS score) (0-35)
Time Frame
Month 1
Title
Urinary symptoms
Description
International Prostate Symptom Score (IPSS score) (0-35)
Time Frame
Month 3
Title
Urinary symptoms
Description
International Prostate Symptom Score (IPSS score) (0-35)
Time Frame
Month 6
Title
Incontinence
Description
24-hr pad test (g)
Time Frame
Month 1
Title
Incontinence
Description
24-hr pad test (g)
Time Frame
Month 3
Title
Incontinence
Description
24-hr pad test (g)
Time Frame
Month 6
Title
Erectile dysfunction
Description
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Time Frame
Month 1
Title
Erectile dysfunction
Description
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Time Frame
Month 3
Title
Erectile dysfunction
Description
International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)
Time Frame
Month 6
Title
Health-related quality of life
Description
euroqol 5 dimension questionnaire (EQ-5D)
Time Frame
Month 1
Title
Health-related quality of life
Description
euroqol 5 dimension questionnaire (EQ-5D)
Time Frame
Month 3
Title
Health-related quality of life
Description
euroqol 5 dimension questionnaire (EQ-5D)
Time Frame
Month 6

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Frandon, MD
Organizational Affiliation
CHU Nimes
Official's Role
Study Director
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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