An evaluation of Focal ablation therapy using High-Intensity Focused Ultrasound in the treatment of localised adenocarcinoma of the prostate

Phase 2

Completed

• Conditions: ocalised prostate cancer; Cancer; Malignant neoplasm of the prostate

• Registration Number: ISRCTN69304414
• Lead Sponsor: niversity College London Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-03
• Study Completion: 2009-05-30
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

1. Men aged 45 - 80 years
2. Histological diagnosis of prostate adenocarcinoma
3. Gleason grade total 7 or less (patterns 3+4 or 4+3 or less acceptable)
4. Cancer prostate-confined only (bilateral or unilateral)
5. Serum prostate specific antigen (PSA) less than or equal to 15 ng/mL
6. A life expectancy of 5 years or more
7. Prostate volume less than or equal to 40 cc or maximum anterior-posterior length less than or equal to 40 mm
8. Has had multi-sequence magnetic resonance imaging (ms-MRI) and transperineal template 5 mm spaced biopsies in the 6 months prior to recruitment
9. All malignant areas are treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and at least one neurovascular bundle is preserved
10. Signed informed consent form by patient

Exclusion Criteria

1. Men who have received androgen suppression within previous 6 months
2. Men who have had previous radiation therapy for prostate cancer
3. Men treated with chemotherapy for prostate cancer
4. Men with evidence of metastatic disease
5. Men with latex allergies
6. Men who have undergone prior significant rectal surgery preventing insertion of transrectal probe
7. Men with intraprostatic calcifications making HIFU of focal areas of cancer untreatable
8. Men who have undergone previous transurethral resection of the prostate or laser prostatectomy in the 5 years prior to recruitment
9. Men who have undergone previous HIFU, cryosurgery, thermal or microwave therapy to the prostate at any point prior to recruitment
10. American Society of Anaesthesiology grades III - IV
11. Men not fit for general anaesthesia or regional anaesthesia as assessed by Consultant Anaesthetist
12. Men unable to have MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implant likely to contribute significant artifact to images)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To determine patient acceptability, feasibility, and side-effect profile by evaluating:<br> 1. Recording of adverse events<br> 2. Urinary symptoms and erectile function will be assessed at each visit with the following questionnaires:<br> 2.1. International Index of Erectile Function-15 [IIEF-15]<br> 2.2. International Prostate Symptom Score [IPSS] and IPSS - Quality of Life (IPSS-QoL)<br> 2.3. Functional Assessment of Cancer Therapy - Prostate (FACT-P)<br> 2.4. Continence questionnaires<br>

Secondary Outcome Measures

Name	Time	Method
<br> To determine the effectiveness of therapy by:<br> 1. Post-treatment biopsies of treated areas at 6 months<br> 2. Post-treatment MRI to evaluate area of necrosis within two weeks and at 6 months<br> 3. Measurement of PSA at each follow-up visit and estimated measurement of time to PSA nadir<br> 4. Recording the need for secondary or adjuvant treatment following therapy<br>