# Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU (High Intensity Focused Ultrasound) Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer

> **NCT03531099** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Hospices Civils de Lyon** · enrollment: 108 (actual)

## Conditions studied

- Prostate Cancer

## Interventions

- **PROCEDURE:** treatment with focal HIFU
- **BIOLOGICAL:** PSA dosage
- **DEVICE:** MRI
- **OTHER:** Questionnaires
- **PROCEDURE:** Prostatic biopsies

## Key facts

- **NCT ID:** NCT03531099
- **Lead sponsor:** Hospices Civils de Lyon
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2018-10-02
- **Primary completion:** 2025-10-02
- **Final completion:** 2026-10-02
- **Target enrollment:** 108 (ACTUAL)
- **Last updated:** 2025-06-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03531099

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03531099, "Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU (High Intensity Focused Ultrasound) Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT03531099. Licensed CC0.

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