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

University of Roma La Sapienza

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Device: ExAblate 2100; InSightec

Study type

Interventional

Funder types

Other

Identifiers

NCT01522118

PCa-MRgFUS-I

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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