Actively Recruiting

Phase Not Applicable
Age: 0 - 90Years
MALE
NCT01194648

Focal Therapy for Prostate Cancer Using HIFU

Led by University College, London · Updated on 2018-04-20

354

Participants Needed

1

Research Sites

935 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Focal Therapy for Prostate Cancer Using HIFU

Who Can Participate

Age: 0 - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate cancer on transrectal or transperineal biopsy
  • Prostate biopsy showing unilateral or limited bilateral disease with specific Gleason scores as detailed in the protocol
  • Stage T1 to T2cN0M0 prostate cancer, with radiological T3a permitted
  • Serum PSA level less than or equal to 20 ng/ml
  • Life expectancy of 10 years or more
  • Signed informed consent
  • Ability to understand English sufficiently to participate
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

University College London

London, England, United Kingdom, WC1E 6BT

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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