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

This study has been completed.
Information provided by (Responsible Party):
Alessandro Napoli, University of Roma La Sapienza Identifier:
First received: January 23, 2012
Last updated: February 25, 2013
Last verified: February 2013

January 23, 2012
February 25, 2013
January 2011
February 2012   (final data collection date for primary outcome measure)
Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Measure of expected or UN-expected adverse events
Same as current
Complete list of historical versions of study NCT01522118 on Archive Site
Efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Measure of ablated area in terms of necrosis vs residual tumor
Same as current
Not Provided
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MR-guided Focused Ultrasound Treatment of Prostate Cancer: Focal Therapy for Locally Non-Advanced Disease
Focal Therapy With Magnetic Resonance Guided Focused Ultrasound Treatment of Locally Non-Advanced Prostate Cancer: Phase 1 Study

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.

Not Provided
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Prostate Cancer
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

Experimental: HIFU
(high intensity focused ultrasound)
Intervention: Device: ExAblate 2100; InSightec
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
February 2012   (final data collection date for primary outcome measure)

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
40 Years to 85 Years
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Alessandro Napoli, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Principal Investigator: alessandro napoli, MD, PhD Department of Radiological Sciences, Sapienza University of Rome
University of Roma La Sapienza
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP