Prostate CancerPhase 2NCT00987675
High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer
A Phase 2 study testing pharmacological study, questionnaire administration and assessment of therapy complications in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
RATIONALE: High-intensity focused ultrasound 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 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
- What is being tested?
- pharmacological study, 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 Jul 2011
- 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 on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria:
- Stage ≤ T3b, N0, M0 disease
- Gleason score ≤ 8
- Serum PSA ≤ 20 ng/mL
- No metastatic disease and nodal spread by staging CT or MRI
- Negative bone scan within the past 6 months
- Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI
- Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved
PATIENT CHARACTERISTICS:
- Able to tolerate a transrectal ultrasound
- Able to undergo major surgery as assessed by a consultant anesthesiologist
- Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant)
- No urethral stricture or presence of metal implants or stents in the urethra
- No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy
- No allergy to latex
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy
- No prior treatment with any of the following:
- Transurethral resection of the prostate or equivalent procedures within the past 2 years
- High-intensity focused ultrasound ablation (HIFU)
- Cryosurgery
- Thermal or microwave therapy to the prostate
- No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe
- More than 12 months since prior androgen suppression or hormone treatment for prostate cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College Hospital
London, England, WIT 3AA
Hashim Uddinn Ahmed, MD, 44-20-7380-9194
About this study
Official title: An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer
RATIONALE: High-intensity focused ultrasound 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 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 and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer.
Secondary
- To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy.
- To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients.
- To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up.
OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment.
Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months.
After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.
- Conditions
- Prostate Cancer
- Being tested
- pharmacological study, questionnaire administration, assessment of therapy complications, high-intensity focused ultrasound ablation, quality-of-life assessment
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III 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.
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.
Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months
Secondary outcomes (3)
Success of treatment as demonstrated by the absence of cancer at 6 months
PSA kinetics after completion of treatment
Proportion of patients 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
- Primary completionJul 2011 (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 2
- Primary purpose
- Treatment
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Hashim Uddinn Ahmed, MD, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987675
- Sponsor's protocol ID
- CDR0000650138
- Other IDs
- UCLH-09-H0714-7
- Status last verified
- Mar 2011
- First submitted
- 30 Sep 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
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 Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer
- ClinicalTrials.gov ID
- NCT00987675
- Acronym / sponsor ID
- CDR0000650138
- Conditions
- Prostate Cancer
- Keywords
- 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
- Primary completion
- Jul 2011 (estimated)
- 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 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 ablation and to see how well it works in treating patients with progressive prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer.
Secondary
- To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy.
- To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients.
- To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up.
OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment.
Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months.
After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| pharmacological study | 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
Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months
3 secondary outcomes
Success of treatment as demonstrated by the absence of cancer at 6 months
PSA kinetics after completion of treatment
Proportion of patients 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.
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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.
Hashim Uddinn Ahmed, MD
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 pharmacological study, questionnaire administration and assessment of therapy complications in people with Prostate Cancer, 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?
Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 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 26 Aug 2013.