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CompletedNCT00561262Updated Aug 26, 2013

High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer

A Phase 2 interventional study of questionnaire administration and high-intensity focused ultrasound ablation in Prostate Cancer, sponsored by University College London Hospitals. Completed at 1 site in United Kingdom. Open to male participants aged Up to 79 Years. Per ClinicalTrials.gov, last updated 2013-08-26.

Sponsored by University College London Hospitals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Ages
Up to 79 Years
Sex
Male
01

Study summary

RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue.

PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine patient acceptability, feasibility, and side-effect profile by evaluating records of adverse events.
  • To determine patient acceptability, feasibility, and side-effect profile by evaluating urinary symptoms and erectile function before study stage 1 (verification), before study stage 2 (treatment), and at each follow-up visit.

Secondary

  • To determine the effectiveness of therapy by post-treatment transrectal ultrasound-guided biopsies at 6 months and if there is evidence of biochemical failure.
  • To determine the effectiveness of therapy by post-treatment MRI to evaluate area of necrosis and presence of any residual tissue.
  • To determine the effectiveness of therapy by measurement of prostate-specific antigen (PSA) at each follow-up visit and measurement of time to PSA nadir.
  • To determine the effectiveness of therapy by recording the need for secondary or adjuvant treatment following therapy.

OUTLINE: Patients undergo hemiablation using high-intensity focused ultrasound to the side of the prostate with cancer and up to 5 mm over into the contralateral side to ensure adequacy.

Patients complete questionnaires periodically during study to assess urinary symptoms and erectile dysfunction. These include the International Index of Erectile Function-15 [IIEF-15]; the International Prostate Symptom Score [IPSS] and IPSS-QoL; the Functional Assessment of Cancer Therapy - Prostate (FACT-P); and the Continence Questionnaire.

After completion of study treatment, patients are followed at 2-7 days, 7-14 days, and at 1, 3, 6, 9, and 12 months.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University College London Hospitals is the lead sponsor of 61 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 79 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:

    • Gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable)
    • Cancer prostate-confined only
    • Cancer confined to one lobe as defined by transrectal ultrasound (TRUS) biopsy
    • Serum prostate-specific antigen (PSA) ≤ 15 ng/mL
    • Prostate volume ≤ 40 cc OR AP length of prostate \< 4 cm
  • Unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence MRI and transperineal template biopsies outside of this trial in similar procedure protocols to this trial
  • No evidence of metastatic disease
  • No intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 5 years
  • No latex allergies
  • No American Society of Anesthesiology surgical risk score III or IV
  • No contraindications to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images)
  • Must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior androgen suppression therapy
  • No prior radiotherapy for prostate cancer
  • No prior chemotherapy for prostate cancer
  • No prior significant rectal surgery preventing insertion of transrectal probe
  • No prior transurethral resection of the prostate or laser prostatectomy
  • No prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
60 participants (estimated)

Interventions

  • Otherquestionnaire administration
  • Procedurehigh-intensity focused ultrasound ablation
  • Procedurequality-of-life assessment
06

What researchers measure

Primary outcomes

  1. Feasibility

  2. Adverse events

  3. Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function

  4. Side effect profile

Secondary outcomes

  1. Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir

  2. Exclusion of cancer on MRI at 2-7 days and at 6 months

  3. Transrectal ultrasound biopsies at 6 months

  4. Need for secondary or adjuvant treatment for prostate cancer following therapy

07

Study locations

1 site
  • University College of London Hospitals
    London, England WIT 3AA, United Kingdom
08

References and documents

Publications

  • Ahmed HU, Freeman A, Kirkham A, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localized prostate cancer: a phase I/II trial. J Urol. 2011 Apr;185(4):1246-54. doi: 10.1016/j.juro.2010.11.079. Epub 2011 Feb 22. PubMed 21334018 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00561262
Lead sponsor
University College London Hospitals
First posted
Nov 20, 2007
Start date
May 2006
Primary completion
Oct 2009
Completion
Apr 2011
Last update
Aug 26, 2013

Study contacts

Mark Emberton, MD, FRCS, MBBS
study chair · University College London Hospitals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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