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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alessandro Napoli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01522118
First received: January 23, 2012
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Device: ExAblate 2100; InSightec
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Focal Therapy With Magnetic Resonance Guided Focused Ultrasound Treatment of Locally Non-Advanced Prostate Cancer: Phase 1 Study

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Measure of expected or UN-expected adverse events


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Measure of ablated area in terms of necrosis vs residual tumor


Enrollment: 12
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIFU
(high intensity focused ultrasound)
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


  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522118

Locations
Italy
Department of Radiological Sciences, Sapienza University of Rome
Rome, Italy, 00100
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: alessandro napoli, MD, PhD Department of Radiological Sciences, Sapienza University of Rome
  More Information

No publications provided

Responsible Party: Alessandro Napoli, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01522118     History of Changes
Other Study ID Numbers: PCa-MRgFUS-I
Study First Received: January 23, 2012
Last Updated: February 25, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Prostate Cancer
High Intensity Focused Ultrasound
Magnetic Resonance guided Focused Ultrasound
Non-invasive therapy
Focal Disease

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014