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

Prostate Cancer Clinical Trial

Official title:

An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00987675
• Other study ID #: CDR0000650138
• Secondary ID: UCLH-09-H0714-7
• Status: Recruiting
• Phase: Phase 2
• First received: September 30, 2009
• Last updated: August 23, 2013
• Start date: July 2009

Study information

• Verified date: March 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 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 ablation and to see how well it works in treating patients with progressive prostate cancer.

Description:

OBJECTIVES:

Primary

• To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer.

Secondary

• To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy.

• To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients.

• To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up.

OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment.

Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months.

After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria:

• Stage = T3b, N0, M0 disease

• Gleason score = 8

• Serum PSA = 20 ng/mL

• No metastatic disease and nodal spread by staging CT or MRI

• Negative bone scan within the past 6 months

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

• Secondary lesions are included in the treatment provided = 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved

PATIENT CHARACTERISTICS:

• Able to tolerate a transrectal ultrasound

• Able to undergo major surgery as assessed by a consultant anesthesiologist

• Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant)

• No urethral stricture or presence of metal implants or stents in the urethra

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

• No allergy to latex

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy

• No prior treatment with any of the following:

• Transurethral resection of the prostate or equivalent procedures within the past 2 years

• High-intensity focused ultrasound ablation (HIFU)

• Cryosurgery

• Thermal or microwave therapy to the prostate

• No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe

• More than 12 months since prior androgen suppression or hormone treatment for prostate cancer

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• pharmacological study

• 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	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	Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months			No
Secondary	Success of treatment as demonstrated by the absence of cancer at 6 months			No
Secondary	PSA kinetics after completion of treatment			No
Secondary	Proportion of patients requiring androgen blockade at 12 months			No