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

Recurrent Prostate Cancer Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00772317
• Other study ID #: FSI-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2008
• Est. completion date: December 2021

Study information

• Verified date: April 2019
• Source: SonaCare Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

Device:
• High Intensity Focused Ultrasound
High Intensity Focused Ultrasound

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	CAN-AM	Toronto	Ontario
United States	Urologic Consultants of SE PA, LLP	Bala-Cynwyd	Pennsylvania
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals of Cleveland Case Medical Center	Cleveland	Ohio
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Metropolitan Urology, PSC	Jeffersonville	Indiana
United States	David Geffen School of Medicine at University of California Los Angeles	Los Angeles	California
United States	Tower Urology	Los Angeles	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Specialists in Urology, P.A.	Naples	Florida
United States	Tulane University	New Orleans	Louisiana
United States	New York University School of Medicine	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Walter Reed National Military Medical Center (Military Personnel Only)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
SonaCare Medical

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	negative prostate biopsy at the 12 month time point		12 months post treatment