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Focal Therapy for Prostate Cancer Using HIFU

NCT01194648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2018-04-20

No results posted yet for this study

Summary

RATIONALE: Prospective trials using hemi-ablation with high intensity focused ultrasound (HIFU) (Sonablate 500) have demonstrated feasibility, safety, and encouraging functional outcomes and early cancer control with 90% of men achieving trifecta status (no erectile dysfunction, leak-free pad-free continence, cancer control). However, these trials have involved small numbers of patients with men selected for good baseline function. A multi-centre prospective trial within a larger cohort of men that better represents the patient population with prostate cancer (external validity) is required.

Conditions

Interventions

OTHER

questionnaire administration

PROCEDURE

assessment of therapy complications

PROCEDURE

high-intensity focused ultrasound ablation

PROCEDURE

multiparametric magnetic resonance imaging

PROCEDURE

quality-of-life assessment

PROCEDURE

transperineal prostate biopsy

PROCEDURE

transrectal prostate biopsy

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Mark Emberton, MD, FRCS, MBBS · University College, London

  • Hashim Uddinn Ahmed, MD, FRCS · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-29
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01194648 on ClinicalTrials.gov