An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer
- 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.
- 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
- 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.
Primary Purpose: Treatment
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
Hashim Uddinn Ahmed, MD
University College London Hospitals