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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SonaCare Medical
ClinicalTrials.gov Identifier:
NCT00772317
First received: October 14, 2008
Last updated: January 11, 2016
Last verified: January 2016
  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 SonaCare Medical:

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 ]

Enrollment: 117
Study Start Date: July 2008
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2016 (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   (Adult, Senior)
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

Locations
United States, California
Tower Urology
Los Angeles, California, United States, 90048
David Geffen School of Medicine at University of California Los Angeles
Los Angeles, California, United States, 90095
United States, District of Columbia
Walter Reed National Military Medical Center (Military Personnel Only)
Washington, District of Columbia, United States, 20307
United States, Florida
Specialists in Urology, P.A.
Naples, Florida, United States, 34102
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Metropolitan Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45206
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Urologic Consultants of SE PA, LLP
Bala Cynwyd, Pennsylvania, United States, 19004
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
CAN-AM
Toronto, Ontario, Canada, M6A 3B5
Sponsors and Collaborators
SonaCare Medical
Investigators
Study Director: Mark Carol, MD SonaCare Medical, LLC
  More Information

Responsible Party: SonaCare Medical
ClinicalTrials.gov Identifier: NCT00772317     History of Changes
Other Study ID Numbers: FSI-003 
Study First Received: October 14, 2008
Last Updated: January 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by SonaCare Medical:
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 December 08, 2016