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Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer | Clinical Trials | Clareo Health

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Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer

A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU

NCT00770822•SonaCare Medical

View on ClinicalTrials.gov

Summary

This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.

Detailed Description

The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the Sonablate arm.

Eligibility

Age

40 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•T1c or T2a carcinoma of the prostate confirmed by biopsy;
•life expectancy of 5(five) years or more;
•prostate biopsy with 10(ten) or more core biopsies;
•Gleason score of 6(six) or less;
•serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
•prostate volume of less than 40(Forty)cc;
•distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less;
•informed consent for the treatment study through 24 months post-treatment follow-up

Exclusion Criteria

•men who have had previous definitive treatment for prostate cancer;
•evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
•prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
•inability to tolerate a transrectal ultrasound;
•active urinary tract infection;
•functional bladder problems;
•prior significant rectal surgery;
•intra-prostatic calcifications greater than 1(One)cm in diameter;
•interest in future fertility;
•prostatic surgery/procedure (except biopsy) within 1(One) year;
+12 more criteria

Locations (6)

Brachytherapy Site: Urology Centers of Alabama

Birmingham, Alabama, United States

Brachytherapy Site: Specialists in Urology

Naples, Florida, United States

Brachytherapy Site: Grand Strand Urology

Myrtle Beach, South Carolina, United States

HIFU Site: Southeast Urology Network

Memphis, Tennessee, United States

HIFU Site: Urology Associates

Nashville, Tennessee, United States

HIFU Site: Urology of San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

April 1, 2007

Primary Completion Date

July 1, 2020

Completion Date

December 1, 2020

Last Updated

April 10, 2019

Enrollment

466

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

HIFU (Sonablate® 500)

DEVICE

Brachytherapy

DEVICE

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC