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Transrectal Prostate Cancer High-Intensity Focused Ultrasound Ablation: Assessment of Tissue Destruction With Shear-wave Ultrasound Elastography


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Transrectal Prostate Cancer High-Intensity Focused Ultrasound Ablation: Assessment of Tissue Destruction With Shear-wave Ultrasound Elastography

Inclusion Criteria


Inclusion Criteria :

- Age > 18 years

- Prostate cancer proved by biopsy

- Prostate cancer not eligible for surgery referred for total or hemi HIFU ablation, OR
prostate cancer local recurrence referred for salvage HIFU ablation

- Anal and rectal normal anatomy

- Life expectancy ≥ 5 years

- Satisfactory general condition (ASA 1 to 3)

- Informed consent signed

- Affiliation to the French social security system or equivalent social security
system.

Exclusion Criteria:

- Patient treated by hormonotherapy

- Prostatic calcifications preventing HIFU ablation

- Distance between rectal mucosa and prostatic capsule ≥ 6 mm

- History of inflammatory bowel disease

- Sclerosis of the bladder neck or urethral stenosis

- Rectal fistula

- Ongoing urinary infection

- Impaired renal function (MDRD < 30mL/min/1,73 m²)

- Severe BPCO

- Acute endocarditis/ Hypercoagulation/ recent thromboembolism

- Latex or sulphur hexafluoride allergy

- Contraindication to the injection of Sonovue®

- Patient on protection of the Court, under supervision or trusteeship

- Inability to express an informed consent

- Patient already enrolled in a study that could interfere with this study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Measurement of the thickness of undestroyed parenchyma

Outcome Description:

Briefly, the thickness of undestroyed parenchyma will be measured on CEUS and D0 SWUE in the anterior, lateral and posterior parts of both prostatic lobes. The thickness (height) of undestroyed parenchyma left at both apex will also be measured. Measurements obtained with CEUS (used as reference) and SWUE will be compared.

Outcome Time Frame:

Day 0

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2012.730

NCT ID:

NCT01729442

Start Date:

October 2012

Completion Date:

February 2016

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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