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

University College London Hospitals26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Sexual Dysfunction

Interventions

laboratory biomarker analysisOTHER

questionnaire administrationOTHER

assessment of therapy complicationsPROCEDURE

high-intensity focused ultrasound ablation

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (1)

University College Hospital - London

London, England, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Total proportion of men with erectile dysfunction and/or incontinence

Quality of life

Secondary Outcomes

Success of index lesion ablation with HIFU at 6 months

Prostate-specific antigen kinetics

Proportion of men requiring androgen blockade at 12 months

Data from ClinicalTrials.gov

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