NCT03407963

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 26, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

December 4, 2025

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

January 9, 2018

Last Update Submit

November 26, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (28)

  • Global survival

    Month 6

  • Use of other mode of treatment

    Month 1

  • Use of other mode of treatment

    Month 3

  • Use of other mode of treatment

    Month 6

  • Necrosis of treated lobe

    Day 0

  • +23 more secondary outcomes

Study Arms (1)

Prostate cancer patients

EXPERIMENTAL
Procedure: Embolization

Interventions

EmbolizationPROCEDURE

Embolization by microparticles (300-500 microns)

Prostate cancer patients

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • Frandon J, Bey E, Hamard A, Mohammad H, Gonzalez S, Greffier J, Chevallier T, de Forges H, Beregi JP, Droupy S. Early Results of Unilateral Prostatic Artery Embolization as a Focal Therapy in Patients with Prostate Cancer under Active Surveillance: Cancer Prostate Embolisation, a Pilot Study. J Vasc Interv Radiol. 2021 Feb;32(2):247-255. doi: 10.1016/j.jvir.2020.10.002. Epub 2020 Nov 25.

    PMID: 33248919RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Julian Frandon, MD

    CHU Nimes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 23, 2018

Study Start

June 26, 2018

Primary Completion

November 3, 2020

Study Completion

November 3, 2020

Last Updated

December 4, 2025

Record last verified: 2020-06

Locations

FR(1)