Status:
COMPLETED
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
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 embolizat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03407963
Start Date
June 26 2018
End Date
November 3 2020
Last Update
December 4 2025
Active Locations (1)
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1
CHU Nimes
Nîmes, France, 30029