Prostate CancerPhase 2NCT00561314
High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
A Phase 2 study testing questionnaire administration, biopsy and high-intensity focused ultrasound ablation in people with Prostate Cancer and Sexual Dysfunction, run by University College London Hospitals at 2 sites in United Kingdom.
Trial summary
RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue. PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Sexual Dysfunction, Urinary Incontinence
- What is being tested?
- questionnaire administration, biopsy and high-intensity focused ultrasound ablation
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2007to Jan 2012
- Phase
- Phase 2
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Low-risk disease, as defined by the following criteria:
- Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
- Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
- Serum PSA ≤ 15 ng/mL
- Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
- Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
- All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
- No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
- No metastatic disease
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 5 years
- Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
- No prior rectal fistula
- No American Society of Anesthesiology grades III-IV
- No latex allergies
- No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
- No moderate to severe inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
- No androgen suppression treatment within the past 6 months
- No transurethral resection of the prostate or laser prostatectomy within the past 5 years
- No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
- No prior significant rectal surgery preventing insertion of transrectal probe
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
University College of London Hospitals
London, England, WIT 3AA
About this study
Official title: An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate.
Secondary
- To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy.
OUTLINE: 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 are then evaluated over a 12-month period.
Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also undergo transrectal ultrasound biopsy at 6 months to evaluate disease response.
Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate erectile and sexual function, urinary flow and continence, and quality-of-life.
- Conditions
- Prostate Cancer, Sexual Dysfunction, Urinary Incontinence
- Being tested
- questionnaire administration, biopsy, high-intensity focused ultrasound ablation, magnetic resonance imaging, quality-of-life assessment
- Keywords
- sexual dysfunction, urinary incontinence, adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Sexual Dysfunction, Physiological, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
biopsyProcedure or surgery
high-intensity focused ultrasound ablationProcedure or surgery
magnetic resonance imagingProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events
Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...
Secondary outcomes (1)
Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Mark Emberton, MD, FRCS, MBBS, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561314
- Sponsor's protocol ID
- CDR0000574344
- Other IDs
- UCLCTC-UCLH-FOCAL-HIFU, EU-20773
- Status last verified
- Jul 2009
- First submitted
- 17 Nov 2007
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17.
PubMed 22512844
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00561314
- Acronym / sponsor ID
- CDR0000574344
- Conditions
- Prostate Cancer, Sexual Dysfunction, Urinary Incontinence
- Keywords
- sexual dysfunction, urinary incontinence, adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Nov 2007 (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 tumor cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate.
Secondary
- To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy.
OUTLINE: 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 are then evaluated over a 12-month period.
Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also undergo transrectal ultrasound biopsy at 6 months to evaluate disease response.
Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate erectile and sexual function, urinary flow and continence, and quality-of-life.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 45 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 |
|---|---|---|
| questionnaire administration | Other | – |
| biopsy | Procedure or surgery | – |
| high-intensity focused ultrasound ablation | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events
Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...
1 secondary outcome
Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...
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 26 Aug 2013.
- Results publication: PubMed 22512844Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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 Emberton, MD, FRCS, MBBS study chair
University College London Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing questionnaire administration, biopsy and high-intensity focused ultrasound ablation in people with Prostate Cancer and Sexual Dysfunction, run by University College London Hospitals at 2 sites in United Kingdom.
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 26 Aug 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 Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00561314, which also lists 1 linked publication.
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 26 Aug 2013.