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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by USHIFU, LLC
Sponsor:
Information provided by (Responsible Party):
USHIFU, LLC
ClinicalTrials.gov Identifier:
NCT00772317
First received: October 14, 2008
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Recurrent Prostate Cancer
Device: High Intensity Focused Ultrasound

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Clinical Study of the Sonablate® 450 (Sonablate) for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

Resource links provided by NLM:


Further study details as provided by USHIFU, LLC:

Primary Outcome Measures:
  • absence of biochemical failure, defined as achieving a PSA nadir of ≤ 0.5 ng/mL within 12 months of treatment [ Time Frame: 12 months post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • negative prostate biopsy at the 12 month time point [ Time Frame: 12 months post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIFU
High Intensity Focused Ultrasound
Device: High Intensity Focused Ultrasound
High Intensity Focused Ultrasound
Other Names:
  • Sonablate 450
  • Sonablate

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

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

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);
  • life expectancy > 12 months.

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;
  • 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;
  • functional bladder problems defined as IPSS > 19;
  • current bladder cancer, urethral stricture, or bladder neck contracture; a cystoscopy my be performed at the investigator's discretion to rule out these conditions;
  • urinary tract or rectal fistula;
  • rectal fibrosis/stenosis; anoscopy or proctoscopy may be performed at the investigator's discretion;
  • anomaly of the rectal anatomy or mucus membrane; anoscopy or proctoscopy may be performed at the investigator's discretion;
  • prostate seroma/abscess;
  • current symptomatic radiation proctitis requiring creams;
  • participation in other investigational studies, unless approved in writing by the study sponsor.
  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: NCT00772317

Contacts
Contact: Jessica Fielding, CCRC, CCRA 877-874-4389 jessicafielding@sonacaremedical.com
Contact: Edgar Gomez, CCRA 877-874-4389 edgargomez@sonacaremedical.com

Locations
United States, California
David Geffen School of Medicine at University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Malu Macairan    310-794-3566    mmacairan@mednet.ucla.edu   
Principal Investigator: Leonard Marks, M.D.         
Principal Investigator: Allan Pantuck, M.D.         
Tower Urology Recruiting
Los Angeles, California, United States, 90048
Contact: Terry Williams    310-854-9898 ext 178    williamst@towerurology.com   
Contact: Himali Karunaratne    310.854.9898 ext 168    karunaratneh@towerurology.com   
Principal Investigator: Matthew Bui, MD, PhD         
United States, District of Columbia
Walter Reed National Military Medical Center (Military Personnel Only) Recruiting
Washington, District of Columbia, United States, 20307
Contact: Abdur Rashid, CRC    301-319-2928    Abdur.Rashid.ctr@health.mil   
Contact: Judy Travis, CCRC    301.319.2927    Judith.A.Travis.ctr@health.mil   
Principal Investigator: COL. David G. McLeod, M.C., M.D.         
United States, Florida
Specialists in Urology, P.A. Completed
Naples, Florida, United States, 34102
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Cindy Franklin    317-274-1798    cf2@iupui.edu   
Principal Investigator: Michael O Koch, MD         
Sub-Investigator: Thomas Gardner, MD         
Metropolitan Urology, PSC Completed
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sree Mandava, MD, MHSA    504-988-0897    smandava@tulane.edu   
Principal Investigator: Benjamin Lee, MD         
United States, New York
Winthrop University Hospitals Recruiting
Mineola, New York, United States, 11501
Contact: Marilyn Richardson    516-663-9587    mrichardson@winthrop.org   
Principal Investigator: Aaron Katz, MD         
New York University School of Medicine Active, not recruiting
New York, New York, United States, 10016
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45206
Contact: Barbara Burke    513-558-4060    burkeb@ucmail.uc.edu   
Principal Investigator: James Donovan, MD         
University Hospitals of Cleveland Case Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Urologic Consultants of SE PA, LLP Active, not recruiting
Bala Cynwyd, Pennsylvania, United States, 19004
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Joan Leahy    215-728-2994    joan.leahy@fccc.edu   
Principal Investigator: David Chen, MD         
United States, Texas
University of Texas M.D. Anderson Cancer Center Completed
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center Active, not recruiting
Madison, Wisconsin, United States, 53792
Canada, Ontario
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 4G5
CAN-AM Active, not recruiting
Toronto, Ontario, Canada, M6A 3B5
Sponsors and Collaborators
USHIFU, LLC
Investigators
Study Director: Mark Schoenberg, MD Johns Hopkins Medical Institution
  More Information

No publications provided

Responsible Party: USHIFU, LLC
ClinicalTrials.gov Identifier: NCT00772317     History of Changes
Other Study ID Numbers: FSI-003
Study First Received: October 14, 2008
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by USHIFU, LLC:
Recurrent
prostate cancer
ebrt
hifu

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 October 01, 2014