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

Prostate Cancer Clinical Trial

Official title:

Focal Therapy With Magnetic Resonance Guided Focused Ultrasound Treatment of Locally Non-Advanced Prostate Cancer: Phase 1 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522118
• Other study ID #: PCa-MRgFUS-I
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2012
• Last updated: February 25, 2013
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• ExAblate 2100; InSightec
Patients with biopsy proven locally non-advanced T2 prostate cancer identified at 3T MR examination including dynamic contrast enhanced (DCE-with time to peak and mean transit time evaluation) and candidate to radical prostatectomy will undergo Magnetic Resonance guided Focused Ultrasound (MRgFUS) ablation. The procedure is carried out either under general anesthesia or spinal block. MR images allow correct identification of the target as well as vital structure to avoid during energy delivery. Treatment safety and efficacy is monitored in real time using MR thermometry. Adjustments of energy direction and intensity can be made according to the real time monitoring. Pre- and post-ablative MR examinations will serve to analyze differences of DCE features of the neoplastic tissue; therapy-induced alterations will also be compared to histopathology findings from whole section prostate specimens

Locations

Country	Name	City	State
Italy	Department of Radiological Sciences, Sapienza University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Measure of expected or UN-expected adverse events	One year	Yes
Secondary	Efficacy	Measure of ablated area in terms of necrosis vs residual tumor	18 months	No