HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
N/A
N/A
Male
Prostate Cancer, Sexual Dysfunction
Trial Information
HIFU Lesion Control in Patients With Non-metastatic 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Total proportion of men with erectile dysfunction and/or incontinence
Safety Issue:
Yes
Principal Investigator
Mark Emberton, MD, FRCS, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
University College London Hospitals
Authority:
Unspecified
Study ID:
CDR0000652331
NCT ID:
NCT00988130
Start Date:
July 2009
Completion Date:
Related Keywords:
- Prostate Cancer
- Sexual Dysfunction
- sexual dysfunction
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
- Sexual Dysfunctions, Psychological
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