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

NCT00772317 | Unknown DMC

• 1 other identifier: FSI-003
• Study Type: interventional
• Target: 117
• Locations: 2 countries
• Sites: 16

Brief Summary

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

Conditions

Recurrent Prostate Cancer

Keywords

Recurrent; prostate cancer; ebrt; hifu

Outcome Measures

Primary Outcomes (1)

• absence of biochemical failure, defined as achieving a PSA nadir of ≤ 0.5 ng/mL within 12 months of treatment

  12 months post treatment

Secondary Outcomes (1)

• negative prostate biopsy at the 12 month time point

  12 months post treatment

Study Arms (1)

HIFU

EXPERIMENTAL

High Intensity Focused Ultrasound

Device: High Intensity Focused Ultrasound

Interventions

High Intensity Focused Ultrasound DEVICE

High Intensity Focused Ultrasound

Also known as: Sonablate 450, Sonablate

HIFU

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• life expectancy \> 12 months.

You may not qualify if:

• 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;
• prior treatment for prostate cancer, other than EBRT or hormone therapy;
• history of urethral stent or urethral surgery (urethral dilation, urethroplasty); a Uroflow exam may be conducted at the investigators discretion;
• prior significant rectal surgery (hemorrhoidectomy is acceptable; rectal resection/fissure repair are excluded);
• history of inflammatory bowel disease of the rectum;
• history of any other malignancy treated within the last 5 years, other than squamous or basal cell skin cancer;

Sponsors & Collaborators

• SonaCare Medical: lead

Study Sites (16)

Tower Urology

Los Angeles, California, 90048, United States

Location

David Geffen School of Medicine at University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Walter Reed National Military Medical Center (Military Personnel Only)

Washington D.C., District of Columbia, 20307, United States

Location

Specialists in Urology, P.A.

Naples, Florida, 34102, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Metropolitan Urology, PSC

Jeffersonville, Indiana, 47130, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45206, United States

Location

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Urologic Consultants of SE PA, LLP

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

CAN-AM

Toronto, Ontario, M6A 3B5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Carol, MD

  SonaCare Medical, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 15, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (14); CA (2)