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

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ClinicalTrials.gov Identifier: NCT03407963
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Embolization Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Prostate cancer patients Procedure: Embolization
Embolization by microparticles (300-500 microns)




Primary Outcome Measures :
  1. Complications arising from embolization [ Time Frame: 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)

  2. Presence of cancerous cells [ Time Frame: Month 6 ]
    Positive/negative according to biopsy of treated lobe


Secondary Outcome Measures :
  1. Global survival [ Time Frame: Month 6 ]
    days

  2. Use of other mode of treatment [ Time Frame: Month 1 ]
    Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)

  3. Use of other mode of treatment [ Time Frame: Month 3 ]
    Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)

  4. Use of other mode of treatment [ Time Frame: Month 6 ]
    Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound)

  5. Necrosis of treated lobe [ Time Frame: Day 0 ]
    MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)

  6. Necrosis of treated lobe [ Time Frame: Week 2 ]
    MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)

  7. Necrosis of treated lobe [ Time Frame: Month 6 ]
    MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)

  8. Change in size of target [ Time Frame: Day 0 ]
    MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)

  9. Change in size of target [ Time Frame: Week 2 ]
    MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)

  10. Change in size of target [ Time Frame: Month 6 ]
    MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm)

  11. Prostate specific antigen level [ Time Frame: Month 1 ]
    ng/ml

  12. Prostate specific antigen level [ Time Frame: Month 3 ]
    ng/ml

  13. Prostate specific antigen level [ Time Frame: Month 6 ]
    ng/ml

  14. Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification [ Time Frame: Month 1 ]
    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).

  15. Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification [ Time Frame: Month 3 ]
    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).

  16. Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification [ Time Frame: 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).

  17. Urinary symptoms [ Time Frame: Month 1 ]
    International Prostate Symptom Score (IPSS score) (0-35)

  18. Urinary symptoms [ Time Frame: Month 3 ]
    International Prostate Symptom Score (IPSS score) (0-35)

  19. Urinary symptoms [ Time Frame: Month 6 ]
    International Prostate Symptom Score (IPSS score) (0-35)

  20. Incontinence [ Time Frame: Month 1 ]
    24-hr pad test (g)

  21. Incontinence [ Time Frame: Month 3 ]
    24-hr pad test (g)

  22. Incontinence [ Time Frame: Month 6 ]
    24-hr pad test (g)

  23. Erectile dysfunction [ Time Frame: Month 1 ]
    International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)

  24. Erectile dysfunction [ Time Frame: Month 3 ]
    International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)

  25. Erectile dysfunction [ Time Frame: Month 6 ]
    International Index of Erectile Function (IIEF-6) questionnaire (score 0-30)

  26. Health-related quality of life [ Time Frame: Month 1 ]
    euroqol 5 dimension questionnaire (EQ-5D)

  27. Health-related quality of life [ Time Frame: Month 3 ]
    euroqol 5 dimension questionnaire (EQ-5D)

  28. Health-related quality of life [ Time Frame: Month 6 ]
    euroqol 5 dimension questionnaire (EQ-5D)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407963


Contacts
Contact: Armand Chevrot, MD +33 (0)6.23.31.86.07 armand.chevrot@chu-nimes.fr

Locations
France
CHU Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Armand Chevrot, MD         
Sub-Investigator: Julien Frandon, MD         
Sub-Investigator: Stéphane Droupy, MD         
Sub-Investigator: Jean-Paul Beregi, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Julian Frandon, MD CHU Nimes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03407963     History of Changes
Other Study ID Numbers: NIMAO/2017-01/JF-01
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases