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

NCT02265159 | Unknown Phase 2

• 1 other identifier: KEK-ZH-Nr. 2013-0415
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (15)

• Biochemical failure

  36 months

• Sensitivity and specificity of MRI imaging

  36 months

• Health care costs

  36 months

• Erectile function

  36 months

• Orgasmic function

  36 months

Study Arms (1)

Focal Therapy Using High Intensity Focused Ultrasound

OTHER

Procedure: Focal Therapy Using High Intensity Focused Ultrasound

Interventions

Focal Therapy Using High Intensity Focused Ultrasound PROCEDURE

Also known as: Focal HIFU

Focal Therapy Using High Intensity Focused Ultrasound

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Zurich: lead
• University College, London: collaborator

Study Sites (1)

Klinik für Urologie, Universitätsspital Zürich

Zurich, Canton of Zurich, 8044, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Daniel Eberli, PD Dr. PhD

  Klinik für Urologie, Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. PhD

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 15, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

CH (1)