Prostate CancerSetPaceNCT00770822
Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer
A study testing HIFU (Sonablate® 500) and Brachytherapy in people with Prostate Cancer, run by SonaCare Medical at 6 sites in United States.
Trial summary
This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HIFU (Sonablate® 500) and Brachytherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2007to Dec 2020
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1c or T2a carcinoma of the prostate confirmed by biopsy;
- life expectancy of 5(five) years or more;
- prostate biopsy with 10(ten) or more core biopsies;
- Gleason score of 6(six) or less;
- serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
- prostate volume of less than 40(Forty)cc;
- distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less;
- informed consent for the treatment study through 24 months post-treatment follow-up
Who cannot join
- men who have had previous definitive treatment for prostate cancer;
- evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
- prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
- inability to tolerate a transrectal ultrasound;
- active urinary tract infection;
- functional bladder problems;
Show all 22Show fewer
- prior significant rectal surgery;
- intra-prostatic calcifications greater than 1(One)cm in diameter;
- interest in future fertility;
- prostatic surgery/procedure (except biopsy) within 1(One) year;
- large median lobe of the prostate;
- use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto);
- current bladder cancer, urethral stricture, or bladder neck contracture;
- urinary tract and/or rectal fistula;
- rectal fibrosis/stenosis;
- anomaly of the rectal anatomy or mucus membrane;
- prostate seroma/abcess;
- prostatitis;
- compromised renal function or upper urinary tract disease secondary to urinary obstruction;
- bleeding disorders/coagulopathy based on measures of PT and PTT;
- implant in the prostate or within 1(One)cm of the prostate;
- zip code of the primary residence of the subject is greater than 200(Two hundred) miles from the clinical site or transportation that would hinder the completion of the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Brachytherapy Site: Urology Centers of Alabama
Birmingham, Alabama, 35209
HIFU Site: Southeast Urology Network
Memphis, Tennessee, 38119
Brachytherapy Site: Grand Strand Urology
Myrtle Beach, South Carolina, 29572
Brachytherapy Site: Specialists in Urology
Naples, Florida, 34102
HIFU Site: Urology Associates
Nashville, Tennessee, 37209
HIFU Site: Urology of San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.
Read the detailed description
The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the Sonablate arm.
- Conditions
- Prostate Cancer
- Being tested
- HIFU (Sonablate® 500), Brachytherapy
- Keywords
- Primary, Prostate, Cancer, Primary T1c/T2a organ confined prostate cancer, organ-confined
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU (Sonablate® 500)Device
Also called SB-500, Sonablate 500, HIFU
High Intensity Focused Ultrasound
BrachytherapyDevice
Also called Raditation Seed Implants, Brachy
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Device, HIFU | Experimental | High Intensity Focused Ultrasound Receives: Device: HIFU (Sonablate® 500) |
| Device, brachytherapy | Active comparator | Brachytherapy Receives: Device: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SonaCare Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Schoenberg, M.D., Principal investigator, Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770822
- Sponsor's protocol ID
- FSI-002
- Acronym
- SetPace
- Status last verified
- Apr 2019
- First submitted
- 9 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® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
- ClinicalTrials.gov ID
- NCT00770822
- Acronym / sponsor ID
- SetPace / FSI-002
- Conditions
- Prostate Cancer
- Keywords
- Primary, Prostate, Cancer, Primary T1c/T2a organ confined prostate cancer, organ-confined
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- SonaCare MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 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.
This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.
Detailed description
The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the Sonablate arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device, HIFU | Experimental | Device: HIFU (Sonablate® 500)High Intensity Focused Ultrasound |
| Device, brachytherapy | Active comparator | Device: BrachytherapyBrachytherapy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- T1c or T2a carcinoma of the prostate confirmed by biopsy;
- life expectancy of 5(five) years or more;
- prostate biopsy with 10(ten) or more core biopsies;
- Gleason score of 6(six) or less;
- serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
Key exclusion criteria (22 listed)
- men who have had previous definitive treatment for prostate cancer;
- evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
- prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
- inability to tolerate a transrectal ultrasound;
- 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 |
|---|---|---|
| HIFU (Sonablate® 500)Also: SB-500, Sonablate 500, HIFUHigh Intensity Focused Ultrasound | Device | Device, HIFU |
| BrachytherapyAlso: Raditation Seed Implants, BrachyStandard of care | Device | Device, brachytherapy |
Primary outcome
The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.
Time frame: 24 Months
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 Schoenberg, M.D. principal investigator
Johns Hopkins Medical Institution
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU (Sonablate® 500) and Brachytherapy in people with Prostate Cancer, run by SonaCare Medical at 6 sites in United States.
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 8 inclusion and 22 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 6 sites in United States. 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?
The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months. (time frame: 24 Months). 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.