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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03407963

NIMAO/2017-01/JF-01

2017-A01915-48 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Prostate cancer patients

Experimental group

Treatment:

Procedure: Embolization