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

NCT ID: NCT00561262

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2011-04-30

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.

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

questionnaire administration

Intervention Type: OTHER

high-intensity focused ultrasound ablation

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University College London Hospitals

OTHER

Sponsor Role: lead

Principal Investigators

Mark Emberton, MD, FRCS, MBBS

Role: STUDY_CHAIR

University College London Hospitals

Locations

University College of London Hospitals

London, England, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 21334018 (View on PubMed)

Other Identifiers

UCLCTC-UCLH-HEMI-HIFU

Identifier Type: -

Identifier Source: secondary_id

EU-20774

Identifier Type: -

Identifier Source: secondary_id

ISRCTN25145525

Identifier Type: -

Identifier Source: secondary_id

CDR0000574367

Identifier Type: -

Identifier Source: org_study_id