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

University College London Hospitals NHS Foundation Trust (UCLH)

Status and phase: Unknown; Phase 2

Conditions: Sexual Dysfunction; Prostate Cancer

Treatments: Procedure: quality-of-life assessment; Procedure: assessment of therapy complications; Procedure: high-intensity focused ultrasound ablation; Other: questionnaire administration; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00988130

EU-20977

UCL-09-H0714-7

CDR0000652331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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