Recurrent Prostate CancerSTARNCT00772317
A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)
A study testing High Intensity Focused Ultrasound in people with Recurrent Prostate Cancer, run by SonaCare Medical at 16 sites in 2 countries.
Trial summary
For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT) Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Recurrent Prostate Cancer
- What is being tested?
- High Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Jul 2008to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites
Urologic Consultants of SE PA, LLP
Bala-Cynwyd, Pennsylvania, 19004
University of Cincinnati
Cincinnati, Ohio, 45206
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, 44106
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Metropolitan Urology, PSC
Jeffersonville, Indiana, 47130
Tower Urology
Los Angeles, California, 90048
David Geffen School of Medicine at University of California Los Angeles
Los Angeles, California, 90095
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Specialists in Urology, P.A.
Naples, Florida, 34102
Tulane University
New Orleans, Louisiana, 70112
New York University School of Medicine
New York, New York, 10016
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Walter Reed National Military Medical Center (Military Personnel Only)
Washington D.C., District of Columbia, 20307
Canada2 sites
London Health Sciences Centre
London, Ontario, N6A 4G5
CAN-AM
Toronto, Ontario, M6A 3B5
About this study
Official title: 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)
Read the 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).
- Conditions
- Recurrent Prostate Cancer
- Being tested
- High Intensity Focused Ultrasound
- Keywords
- Recurrent, prostate cancer, ebrt, hifu
- Medical subject headings
- Prostatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused UltrasoundDevice
Also called Sonablate 450, Sonablate
High Intensity Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Experimental | High Intensity Focused Ultrasound Receives: Device: High Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of biochemical failure, defined as achieving a PSA nadir of ≤ 0.5 ng/mL within 12 months of treatment
Measured: 12 months post treatment
Secondary outcomes (1)
negative prostate biopsy at the 12 month time point
Measured: 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- SonaCare Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Carol, MD, Study director, SonaCare Medical, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772317
- Sponsor's protocol ID
- FSI-003
- Acronym
- STAR
- Status last verified
- Apr 2019
- First submitted
- 14 Oct 2008
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of the Sonablate® 450 (Sonablate) for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)
- ClinicalTrials.gov ID
- NCT00772317
- Acronym / sponsor ID
- STAR / FSI-003
- Conditions
- Recurrent Prostate Cancer
- Keywords
- Recurrent, prostate cancer, ebrt, hifu
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (actual)
- Lead sponsor
- SonaCare MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT)
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU | Experimental | Device: High Intensity Focused UltrasoundHigh Intensity Focused Ultrasound |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused UltrasoundAlso: Sonablate 450, SonablateHigh Intensity Focused Ultrasound | Device | HIFU |
Primary outcome
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
1 secondary outcome
negative prostate biopsy at the 12 month time point
Time frame: 12 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Carol, MD study director
SonaCare Medical, LLC
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Focused Ultrasound in people with Recurrent Prostate Cancer, run by SonaCare Medical at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.