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A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial) | Clinical Trials | Clareo Health

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A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

A Multicenter Clinical Study of the Sonablate® 450 (Sonablate) for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

NCT00772317•SonaCare Medical

View on ClinicalTrials.gov

Summary

For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT)

Detailed Description

The proposed study is a non-randomized, prospective, single arm study. The safety and effectiveness of the Sonablate treatment in subjects with locally recurrent prostate cancer will be evaluated with regard to freedom from biochemical failure and disease recurrence following HIFU treatment. Men with histologically confirmed, locally recurrent, organ-confined, non-metastatic prostatic adenocarcinoma two or more years following EBRT, PSA ≥0.5 ng/mL and ≤10 ng/mL, 40 to 85 years of age, and with initial staging of T1c-T2 prior to radiation, who meet the criteria for salvage treatment, will be enrolled. This pivotal study will cover pre-treatment through the 12-month post-treatment follow-up visit (8 visits). A 5 year extended follow-up study will be conducted annually for the 2nd-5th years post treatment (4 additional visits).

Eligibility

Age

40 - 85 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•subjects with initial presentation of organ confined recurrent prostate cancer (Stages T1c and T2 only) who have been treated with EBRT (conventional, 3D conformal, or IMRT) or proton therapy, two or more years prior, and currently have biopsy proven local recurrence. Previous radiation therapy must be a documented therapeutic dose of 60 to 81Gy or GyE (gray equivalent) for proton therapy;
•Negative bone scan within 6 months prior to enrollment to rule out possibility of metastases;
•Negative CT scans of the chest, abdomen, and pelvis within 6 months prior to enrollment to rule out possibility of metastases;
•age ≥40 years through ≤85 years of age;
•prostate biopsy with ≥10 core biopsies demonstrating 1 or more cores positive for cancer cells, within 6 months prior to treatment;
•prostate volume ≤ 40 gms(cc) (HIFU subject prostate volume will be initially calculated utilizing TRUS measurements during screening and verified with the use of the Sonablate before initiating the HIFU procedure. Patients with prostate volumes greater than 40 gm(cc) as determined by either measurement will not be enrolled in the study);
•AP diameter of the prostate must be ≤4.0cm;
•serum prostate specific antigen (PSA) ≥0.5 ng/mL and ≤10 ng/mL;
•\>90 days post hormone therapy usages, subjects who have or are currently undergoing hormone therapy (GnRH agonist/antagonist) must discontinue hormone therapy and go through a 90 day washout period prior to consideration for study participation, and must remain off hormone therapy throughout the duration of the follow-up period (5 years);
•signed informed consent for the HIFU treatment study through the 12 month follow-up visit (7 visits) and then through the extended follow-up period of 5 years (4 additional visits);
+1 more criteria

Exclusion Criteria

•American Society of Anesthesiologists (ASA) criteria of IV or higher;
•intra-prostatic calcifications \>1.0 cm (single or continuous grouping) on 2 or more consecutive images along the same plane by either the TRUS or Sonablate 500 measurement will not be enrolled;
•active, uncorrected bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, or INR at the time of HIFU (use international lab normal ranges for parameters);
•use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped;
•active urinary tract infection;
•interest in future fertility;
•body weight which would preclude proper suprapubic catheter functioning, per investigator's discretion
•inability to visualize the prostatic tissue adequately on transrectal ultrasound imaging;
•use of any 5ARI drugs within 3 months prior to enrollment such as Finasteride (Proscar) or Dutasteride (Avodart);
•a debulking transurethral resection of the prostate (TURP) is not acceptable once the screening biopsy for patient selection has been conducted;
+13 more criteria

Locations (16)

Tower Urology

Los Angeles, California, United States

David Geffen School of Medicine at University of California Los Angeles

Los Angeles, California, United States

Walter Reed National Military Medical Center (Military Personnel Only)

Washington D.C., District of Columbia, United States

Specialists in Urology, P.A.

Naples, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Metropolitan Urology, PSC

Jeffersonville, Indiana, United States

Tulane University

New Orleans, Louisiana, United States

New York University School of Medicine

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

December 1, 2020

Completion Date

December 1, 2021

Last Updated

April 10, 2019

Enrollment

117

ACTUAL participants

Conditions

Recurrent Prostate Cancer

Interventions

High Intensity Focused Ultrasound

DEVICE

Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

NCT01923506

Recurrent Prostate CancerStage I Prostate Cancer+3 more

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NOT_YET_RECRUITINGPHASE2

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

NCT07365423

Recurrent Prostate Cancer

View study

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.

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A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

Inclusion Criteria

Exclusion Criteria

Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

Treatment of Locally Recurrent Prostate Cancer

Intensive Diet and Exercise or Standard of Care in Improving Physical Function and Quality of Life in Patients With Prostate Cancer Undergoing Androgen Deprivation Therapy

MRI Guided Transurethral HIFU for Various Prostate Diseases

Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients