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

Prostate Cancer Clinical Trial

Official title:

An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561262
• Other study ID #: CDR0000574367
• Secondary ID: UCLCTC-UCLH-HEMI
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2007
• Last updated: August 23, 2013
• Start date: May 2006
• Est. completion date: April 2011

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 79 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• questionnaire administration

Procedure:
• high-intensity focused ultrasound ablation

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	University College of London Hospitals	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility			No
Primary	Adverse events			Yes
Primary	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			No
Primary	Side effect profile			Yes
Secondary	Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir			No
Secondary	Exclusion of cancer on MRI at 2-7 days and at 6 months			No
Secondary	Transrectal ultrasound biopsies at 6 months			No
Secondary	Need for secondary or adjuvant treatment for prostate cancer following therapy			No