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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02265159
• Other study ID #: KEK-ZH-Nr. 2013-0415
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 29, 2014
• Last updated: October 26, 2016
• Start date: May 2014
• Est. completion date: May 2020

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: Daniel Eberli, PD Dr. PhD
• Phone: +41 44 255 95 49
• Email: Daniel.Eberli[@]usz.ch
• Is FDA regulated: No
• Health authority: Ethikkommission: Switzerland
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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.

• 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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Focal Therapy Using High Intensity Focused Ultrasound

Locations

Country	Name	City	State
Switzerland	Klinik für Urologie, Universitätsspital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University College, London

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	36 months	No
Primary	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	36 months	No
Secondary	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	36 months	No
Secondary	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	36 months	No
Secondary	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.	36 months	No
Secondary	Erectile function	Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)	36 months	No
Secondary	Orgasmic function	Rate of loss of ejaculation and orgasm (measured by the IIEF-15)	36 months	No
Secondary	Sexual function	Rate of pain during intercourse	36 months	No
Secondary	Erectile function	Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)	36 months	No
Secondary	Continence	Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)	36 months	No
Secondary	Continence	Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)	36 months	No
Secondary	Lower urinary tract symptoms	Rate of lower urinary tract symptoms (as determined by IPSS scores)	36 months	No
Secondary	Bowel function	Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )	36 months	No
Secondary	Anxiety	Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer	36 months	No
Secondary	Quality of life	General health related quality of life (measured using FACT-P Version 4 )	36 months	No
Secondary	General histological outcome	To determine the histological outcomes at 6, 12 and 36 months	36 months	No
Secondary	Secondary intervention	Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)	36 months	No