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

NCT ID: NCT03407963

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2020-11-03

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate cancer patients

Group Type: EXPERIMENTAL

Embolization

Intervention Type: PROCEDURE

Embolization by microparticles (300-500 microns)

Interventions

Embolization

Embolization by microparticles (300-500 microns)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Frandon, MD

Role: STUDY_DIRECTOR

CHU Nimes

Locations

CHU Nimes

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 33248919 (View on PubMed)

Other Identifiers

2017-A01915-48

Identifier Type: OTHER

Identifier Source: secondary_id

NIMAO/2017-01/JF-01

Identifier Type: -

Identifier Source: org_study_id