NCT02016040

Focal Therapy Using HIFU for Localised Prostate Cancer

Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Jewish General Hospital · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®). Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment. A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	High Intensity Focused Ultrasound

Timeline

• Start date: 2013-03-17
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2013-12-19
• Last updated: 2017-04-19

Locations

1 site across 1 country: Canada