Prostate CancerPhase 1NCT00030277
High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
A Phase 1 study testing high-intensity focused ultrasound ablation in people with Prostate Cancer, run by Focus Surgery at 2 sites in United States.
Trial summary
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue. PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- high-intensity focused ultrasound ablation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2001to Dec 2008
- Phase
- Phase 1
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed locally recurrent prostate cancer after prior brachytherapy or external-beam radiotherapy for initial diagnosis of organ-confined disease (clinical stage T1 or T2 only)
- Prostatic fossa biopsy positive for cancer cells
- Gleason score no greater than 7
- PSA levels 0.5-10 ng/mL
- Able to adequately visualize local recurrence on transrectal ultrasound imaging
- No prostate calcification greater than 5 mm
- No metastases by bone scan
PATIENT CHARACTERISTICS:
Age:
- 40 to 80
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No bleeding disorder as determined by abnormal PT and PTT
Renal:
- No active urinary tract infection
- No history of urinary bladder neck contracture
Other:
- No prior allergy to latex
- No Anesthesia Surgical Assignment (ASA) category IV or greater
- No interest in future fertility
- No history of inflammatory bowel disease
- No other concurrent major nonmalignant debilitating illness
- No other prior or concurrent malignancy except skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for prostate cancer
Chemotherapy:
- No prior chemotherapy for prostate cancer
Endocrine therapy:
- At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
- No prior radical prostatectomy
- No prior transurethral resection of prostate
- No prior urethral stent
- No prior major rectal surgery
Other:
- No prior thermotherapy
- No other prior therapy for prostate cancer
- No concurrent warfarin or other anticoagulant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Long Island College Hospital
Brooklyn, New York, 11201
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
About this study
Official title: Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer.
Read the detailed description
OBJECTIVES:
- Determine the ability of Sonablate to focus ultrasound waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with locally recurrent prostate cancer.
OUTLINE: Patients are stratified according to prior treatment failure (brachytherapy vs post-external beam radiotherapy).
A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU.
Patients are followed at 2, 14, 30, 90, and 180 days.
PROJECTED ACCRUAL: A total of 20 patients (10 per stratum) will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- high-intensity focused ultrasound ablation
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity focused ultrasound ablationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
- Primary completionOct 2007
- Study completionDec 2008
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 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Focus Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael O. Koch, MD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030277
- Sponsor's protocol ID
- FOCUS-G000280
- Other IDs
- CDR0000069125, IUMC-010235, NCI-V01-1683
- Status last verified
- Dec 2008
- First submitted
- 14 Feb 2002
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System
- ClinicalTrials.gov ID
- NCT00030277
- Acronym / sponsor ID
- FOCUS-G000280
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, recurrent prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Focus SurgeryIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer.
Detailed description
OBJECTIVES:
- Determine the ability of Sonablate to focus ultrasound waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with locally recurrent prostate cancer.
OUTLINE: Patients are stratified according to prior treatment failure (brachytherapy vs post-external beam radiotherapy).
A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU.
Patients are followed at 2, 14, 30, 90, and 180 days.
PROJECTED ACCRUAL: A total of 20 patients (10 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 ultrasound ablation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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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.
Michael O. Koch, MD study chair
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing high-intensity focused ultrasound ablation in people with Prostate Cancer, run by Focus Surgery at 2 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?
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: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 Jul 2013.