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Prostate CancerPhase 2/3NCT02265159

Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer

A Phase 2/3 study testing Focal Therapy Using High Intensity Focused Ultrasound in people with Prostate Cancer, run by University of Zurich at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators aim to evaluate cancer control, genitourinary, rectal and overall health-related quality of life outcomes and effectiveness of focal therapy for localised prostate cancer using High Intensity Focused Ultrasound (HIFU). Read more about this study

Who is it for?
Ages 40 to 99 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Focal Therapy Using High Intensity Focused Ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSwitzerland
Study dates
May 2014to May 2020
Phase
Phase 2/3
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 99 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
  • Template biopsy:
  • unilateral disease (Gleason ≤4+3)
  • bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of >50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and <50% of biopsy cores positive on any one side but with dominant disease burden on one side
  • Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
  • Serum PSA ≤15
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  • Life expectancy of ≥10 years
  • Signed informed consent by patient
  • An understanding of the German language sufficient to understand written and verbal information about the trial and consent process

Who cannot join

  • Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
  • Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
  • Men with an inability to tolerate a transrectal ultrasound
  • Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
  • Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
  • Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
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  • Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
  • Men not fit for major surgery as assessed by a Consultant Anaesthetist
  • Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
  • Presence of metal implants/stents in the urethra
  • Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
  • Men with renal impairment with a glomerular filtration rate of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).

Trial locations and contacts

1 site in 1 country.

Daniel Eberli, PD Dr. PhD contact

+41 44 255 95 49

Daniel.Eberli@usz.ch

Ashkan Mortezavi, Dr. contact

+41 44 255 11 11

Ashkan.Mortezavi@usz.ch

Switzerland1 site, 1 recruiting

  • Klinik für Urologie, Universitätsspital Zürich

    Zurich, Canton of Zurich, 8044

    Daniel Eberli, PD Dr. PhD, +41 44 255 95 49, Daniel.Eberli@usz.ch

    Ashkan Mortezavi, Dr., +41 44 255 11 11, Ashkan.Mortezavi@usz.ch

    Recruiting

Other trials in Switzerland

About this study

The investigators aim to evaluate cancer control, genitourinary, rectal and overall health-related quality of life outcomes and effectiveness of focal therapy for localised prostate cancer using High Intensity Focused Ultrasound (HIFU).

Conditions
Prostate Cancer
Being tested
Focal Therapy Using High Intensity Focused Ultrasound
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focal Therapy Using High Intensity Focused UltrasoundProcedure or surgery

    Also called Focal HIFU

Study groups in NCT02265159
Study groupRoleWhat they receive
Focal Therapy Using High Intensity Focused UltrasoundOtherNot described
Receives: Procedure: Focal Therapy Using High Intensity Focused Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oncological safety

    To determine the proportion of men who are free of clinically significant prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU

    Measured: 36 months

  2. Oncological safety

    To determine the proportion of men who are free of any prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU

    Measured: 36 months

Secondary outcomes (15)

  1. Biochemical failure

    To analyse the rate of biochemical recurrence by measuring PSA values following focal therapy using HIFU:

    • biochemical recurrence defined according to the Phoenix Consensus OR
    • by PSA velocity >1 ng/ml/year OR PSA doubling time </=3 years

    Measured: 36 months

  2. Sensitivity and specificity of MRI imaging

    To determine the clinical validity (area under the receiver operating characteristics curve (AUC), sensitivity, specificity, negative and positive predictive values, inter-observer variability) of

    • multi-parametric MR-imaging to predict presence of clinically significant prostate cancer on transperineal template prostate mapping biopsies prior to focal therapy
    • MR-imaging changes to predict presence of residual/recurrent clinically significant prostate cancer on biopsy

    Measured: 36 months

  3. Health care costs

    To determine the costs of treatment and longitudinal morbidity associated with complications at 36 months compared to other treatments of localized prostate cancer.

    Measured: 36 months

  4. Erectile function

    Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)

    Measured: 36 months

  5. Orgasmic function

    Rate of loss of ejaculation and orgasm (measured by the IIEF-15)

    Measured: 36 months

  6. Sexual function

    Rate of pain during intercourse

    Measured: 36 months

  7. Erectile function

    Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)

    Measured: 36 months

  8. Continence

    Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)

    Measured: 36 months

  9. Continence

    Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)

    Measured: 36 months

  10. Lower urinary tract symptoms

    Rate of lower urinary tract symptoms (as determined by IPSS scores)

    Measured: 36 months

  11. Bowel function

    Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )

    Measured: 36 months

  12. Anxiety

    Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer

    Measured: 36 months

  13. Quality of life

    General health related quality of life (measured using FACT-P Version 4 )

    Measured: 36 months

  14. General histological outcome

    To determine the histological outcomes at 6, 12 and 36 months

    Measured: 36 months

  15. Secondary intervention

    Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2020 (estimated)
  4. Study completionMay 2020 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02265159
Sponsor's protocol ID
KEK-ZH-Nr. 2013-0415
Status last verified
Oct 2016
First submitted
29 Sep 2014
Last updated
27 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Focal Therapy Using High Intensity Focused Ultrasound in people with Prostate Cancer, run by University of Zurich at 1 site in Switzerland.

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 9 inclusion and 12 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 27 Oct 2016. 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 Switzerland. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Daniel Eberli, PD Dr. PhD (+41 44 255 95 49, Daniel.Eberli@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oncological safety (time frame: 36 months). 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 NCT02265159.

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 27 Oct 2016.

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