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

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

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

Study Overview

• Status: Unknown
• Conditions: Recurrent Prostate Cancer
• Intervention / Treatment: Device: High Intensity Focused Ultrasound

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).

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIFU; High Intensity Focused Ultrasound	Device: High Intensity Focused Ultrasound; High Intensity Focused Ultrasound; Other Names: Sonablate 450; Sonablate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
negative prostate biopsy at the 12 month time point	12 months post treatment

Collaborators and Investigators

• Sponsor: SonaCare Medical
• Investigators: Study Director: Mark Carol, MD, SonaCare Medical, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 14, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: prostate cancer; Recurrent; ebrt; hifu
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: FSI-003