MR-guided Focused Ultrasound Treatment of Prostate Cancer: Focal Therapy for Locally Non-Advanced Disease

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Device: ExAblate 2100; InSightec

• Registration Number: NCT01522118
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Since prostate specific antigen (PSA) was introduced as a clinical screening tool for prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced disease. The present choice of treatment for men with localized prostate cancer lies between active surveillance and radical therapy. Thus, the option of treating only the cancer within the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very controversial. At present there are no consistent scientific data on focal therapy and its major effectiveness.

Focal therapy for prostate cancer is defined as therapy that selectively ablates known disease while preserving existing functions, with the overall aim of minimizing lifetime morbidity without compromising life expectancy.

The aim of the investigators study is to test if Magnetic Resonance guided Focused Ultrasound ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer.

The study i designed as Phase 1, treatment \& resection protocol. With this project the investigators further aim to evaluate the safety and identify side effects of Magnetic Resonance guided Focused Ultrasound in treating focal prostate cancer.

This design will also expand knowledge of the effect of Magnetic Resonance guided Focused Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted after this non-invasive treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-25
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Patient of age between 40 to 85
• Patient with organ-confined Pca (cT1c and cT2a, N0, M0), diagnosed with TRUS biopsy (min:12 cores)
• Patient with PSA ≤ 10 ng/mL
• Gleason score 6 (3+3) or max 7 (3+4)
• Up to two (2) MR identifiable lesions
• No definite evidence of extracapsular extension

Exclusion Criteria

• Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
• Any rectal pathology, anomaly or previous treatment
• Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall
• Bladder cancer
• Seminal vesicle/lymph node
• Prostate with multiple cystic lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIFU	ExAblate 2100; InSightec	(high intensity focused ultrasound)

Primary Outcome Measures

Name	Time	Method
Safety	One year	Measure of expected or UN-expected adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy	18 months	Measure of ablated area in terms of necrosis vs residual tumor

Trial Locations

Locations (1)

Department of Radiological Sciences, Sapienza University of Rome; 🇮🇹 Rome, Italy