Prostate CancerPhase 2NCT00988130
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
A Phase 2 study testing laboratory biomarker analysis, questionnaire administration and assessment of therapy complications in people with Prostate Cancer and Sexual Dysfunction, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells. PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Sexual Dysfunction
- What is being tested?
- laboratory biomarker analysis, questionnaire administration and assessment of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to not given
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies
- Stage ≤ T3bN0M0
- Gleason grade ≤ 8
- Serum PSA ≤ 20 ng/mL
- Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease
- No metastatic disease and/or nodal spread by CT scan or MRI
- Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI
- No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy
PATIENT CHARACTERISTICS:
- Able to tolerate a transrectal ultrasound
- Not allergic to latex
- Fit for major surgery as assessed by a consultant anaesthetist
- Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.)
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy
- No androgen suppression and/or hormone treatment within the past 12 months
- No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases)
- No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years
- No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College Hospital - London
London, England, WIT 3AA
Mark Emberton, MD, FRCS, MBBS, 44-20-7380-9194
About this study
Official title: HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells.
PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer.
- To evaluate the quality of life of patients treated with this regimen.
Secondary
- To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy.
- To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen.
- To evaluate the proportion of men who require androgen blockade at 12 months of follow-up.
OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease.
Blood samples and prostate biopsies are collected periodically for further analysis.
Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.
- Conditions
- Prostate Cancer, Sexual Dysfunction
- Being tested
- laboratory biomarker analysis, questionnaire administration, assessment of therapy complications, high-intensity focused ultrasound ablation, quality-of-life assessment
- Keywords
- sexual dysfunction, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
questionnaire administrationOther
assessment of therapy complicationsProcedure or surgery
high-intensity focused ultrasound ablationProcedure 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.
Total proportion of men with erectile dysfunction and/or incontinence
Quality of life
Secondary outcomes (3)
Success of index lesion ablation with HIFU at 6 months
Prostate-specific antigen kinetics
Proportion of men requiring androgen blockade at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startJul 2009
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
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Mark Emberton, MD, FRCS, MBBS, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988130
- Sponsor's protocol ID
- CDR0000652331
- Other IDs
- UCL-09-H0714-7, EU-20977
- Status last verified
- May 2011
- First submitted
- 30 Sep 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Ahmed HU, Dickinson L, Charman S, Weir S, McCartan N, Hindley RG, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study. Eur Urol. 2015 Dec;68(6):927-36. doi: 10.1016/j.eururo.2015.01.030. Epub 2015 Feb 11.
PubMed 25682339
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
- HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
- ClinicalTrials.gov ID
- NCT00988130
- Acronym / sponsor ID
- CDR0000652331
- Conditions
- Prostate Cancer, Sexual Dysfunction
- Keywords
- sexual dysfunction, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Jul 2009
- First posted
- 1 Oct 2009 (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: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells.
PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer.
- To evaluate the quality of life of patients treated with this regimen.
Secondary
- To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy.
- To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen.
- To evaluate the proportion of men who require androgen blockade at 12 months of follow-up.
OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease.
Blood samples and prostate biopsies are collected periodically for further analysis.
Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| high-intensity focused ultrasound ablation | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Total proportion of men with erectile dysfunction and/or incontinence
Quality of life
3 secondary outcomes
Success of index lesion ablation with HIFU at 6 months
Prostate-specific antigen kinetics
Proportion of men requiring androgen blockade at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 25682339Ahmed HU, Dickinson L, Charman S, Weir S, McCartan N, Hindley RG, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study. Eur Urol. 2015 Dec;68(6):927-36. doi: 10.1016/j.eururo.2015.01.030. Epub 2015 Feb 11.
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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 Emberton, MD, FRCS, MBBS principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laboratory biomarker analysis, questionnaire administration and assessment of therapy complications in people with Prostate Cancer and Sexual Dysfunction, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total proportion of men with erectile dysfunction and/or incontinence. 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 NCT00988130, 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.