NCT00561262

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started May 2006

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 26, 2013

Status Verified

June 1, 2009

Enrollment Period

3.4 years

First QC Date

November 17, 2007

Last Update Submit

August 23, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (4)

  • Feasibility

  • Adverse events

  • 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

  • Side effect profile

Secondary Outcomes (4)

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

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

  • Transrectal ultrasound biopsies at 6 months

  • Need for secondary or adjuvant treatment for prostate cancer following therapy

Interventions

questionnaire administrationOTHER
high-intensity focused ultrasound ablationPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

AgeUp to 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21334018RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Intensity Focused Ultrasound Ablation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Mark Emberton, MD, FRCS, MBBS

    University College London Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2007

First Posted

November 20, 2007

Study Start

May 1, 2006

Primary Completion

October 1, 2009

Study Completion

April 1, 2011

Last Updated

August 26, 2013

Record last verified: 2009-06

Locations

GB(1)