High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00988130
• Other study ID #: CDR0000652331
• Secondary ID: UCL-09-H0714-7EU
• Status: Recruiting
• Phase: Phase 2
• First received: September 30, 2009
• Last updated: August 23, 2013
• Start date: July 2009

Study information

• Verified date: May 2011
• 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 focal ablation uses high-energy sound waves to kill tumor cells.

PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.

Description:

OBJECTIVES:

Primary

• To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer.

• To evaluate the quality of life of patients treated with this regimen.

Secondary

• To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy.

• To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen.

• To evaluate the proportion of men who require androgen blockade at 12 months of follow-up.

OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease.

Blood samples and prostate biopsies are collected periodically for further analysis.

Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies

• Stage = T3bN0M0

• Gleason grade = 8

• Serum PSA = 20 ng/mL

• Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease

• No metastatic disease and/or nodal spread by CT scan or MRI

• Index lesion or other secondary lesions with a volume = 0.5 cc by MRI

• No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy

PATIENT CHARACTERISTICS:

• Able to tolerate a transrectal ultrasound

• Not allergic to latex

• Fit for major surgery as assessed by a consultant anaesthetist

• Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.)

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy

• No androgen suppression and/or hormone treatment within the past 12 months

• No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases)

• No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years

• No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Sexual Dysfunction

Intervention

Other:
• laboratory biomarker analysis

• questionnaire administration

Procedure:
• assessment of therapy complications

• high-intensity focused ultrasound ablation

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	University College Hospital - London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total proportion of men with erectile dysfunction and/or incontinence			Yes
Primary	Quality of life			No
Secondary	Success of index lesion ablation with HIFU at 6 months			No
Secondary	Prostate-specific antigen kinetics			No
Secondary	Proportion of men requiring androgen blockade at 12 months			No