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Completed

NCT Number: NCT03407963

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

embolization

Procedure

Embolization by microparticles (300-500 microns)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: CAPEMBOL

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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