Clinical trial · Interventional
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
NCT03407963CI-TRIAL-00098421CAPEMBOLcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate cancer patients
- interventionNames
- Procedure: Embolization
Primary outcomes (2)
- measure
- Complications arising from embolization
- timeFrame
- Month 6
- description
- Presence/absence of complications beyond those expected linked to embolization (persistent urinary infection, dysuria, rectorrhagia, hematuria, hemospermia, acute urinary retention and pelvic perineal pain)
- measure
- Presence of cancerous cells
- timeFrame
- Month 6
- description
- Positive/negative according to biopsy of treated lobe
Secondary outcomes (28)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFrandon 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 33248919