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Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

NCT04307056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3862

Last updated 2023-01-12

No results posted yet for this study

Summary

to compare the efficacy of HIFU treatment with standard treatment in two situations:

1. as first-line cancer treatment, HIFU is compared to radical prostatectomy.
2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.

Conditions

Interventions

PROCEDURE

Radical Prostatectomy

The surgical approach can be open or laparoscopic. The procedure begins with lymph node dissection for the intermediate risk groups (PSA \> 10 ng/mL and/or presence of grade 4 Gleason score). Total prostatectomy includes removal of the seminal vesicles. It can preserve 1 or 2 neurovascular bundles, depending on the cancer stage and/or the choice expressed by the patient. The vesicourethral suture is either a running or interrupted suture, and there is drainage by a bladder catheter for at least 5 days.

PROCEDURE

High Intensity Focused Ultrasound (HIFU) Treatment

The treatment with High Intensity Focused Ultrasound (HIFU) evaluated in this study will be delivered by 2 types of medical devices currently available on the market, Ablatherm® and Focal One®. They are both computer-controlled and provided with an endo-rectal probe with integrated ultrasound, enabling planning and the monitoring of treatment of localized prostate cancer in realtime.

Sponsors & Collaborators

  • Association Francaise d'Urologie

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-23
Primary Completion
2022-08-24
Completion
2022-08-24

Countries

  • France
  • Guadeloupe

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307056 on ClinicalTrials.gov