An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
N/A
79 Years
Male
Prostate Cancer
Trial Information
An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
OBJECTIVES:
Primary
- To determine patient acceptability, feasibility, and side-effect profile by evaluating
records of adverse events.
- To determine patient acceptability, feasibility, and side-effect profile by evaluating
urinary symptoms and erectile function before study stage 1 (verification), before
study stage 2 (treatment), and at each follow-up visit.
Secondary
- To determine the effectiveness of therapy by post-treatment transrectal
ultrasound-guided biopsies at 6 months and if there is evidence of biochemical failure.
- To determine the effectiveness of therapy by post-treatment MRI to evaluate area of
necrosis and presence of any residual tissue.
- To determine the effectiveness of therapy by measurement of prostate-specific antigen
(PSA) at each follow-up visit and measurement of time to PSA nadir.
- To determine the effectiveness of therapy by recording the need for secondary or
adjuvant treatment following therapy.
OUTLINE: Patients undergo hemiablation using high-intensity focused ultrasound to the side
of the prostate with cancer and up to 5 mm over into the contralateral side to ensure
adequacy.
Patients complete questionnaires periodically during study to assess urinary symptoms and
erectile dysfunction. These include the International Index of Erectile Function-15
[IIEF-15]; the International Prostate Symptom Score [IPSS] and IPSS-QoL; the Functional
Assessment of Cancer Therapy - Prostate (FACT-P); and the Continence Questionnaire.
After completion of study treatment, patients are followed at 2-7 days, 7-14 days, and at 1,
3, 6, 9, and 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate, meeting the following
criteria:
- Gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable)
- Cancer prostate-confined only
- Cancer confined to one lobe as defined by transrectal ultrasound (TRUS) biopsy
- Serum prostate-specific antigen (PSA) ≤ 15 ng/mL
- Prostate volume ≤ 40 cc OR AP length of prostate < 4 cm
- Unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless
the patient has had multi-sequence MRI and transperineal template biopsies outside of
this trial in similar procedure protocols to this trial
- No evidence of metastatic disease
- No intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 5 years
- No latex allergies
- No American Society of Anesthesiology surgical risk score III or IV
- No contraindications to MRI scanning (e.g., severe claustrophobia, permanent cardiac
pacemaker, or metallic implant likely to contribute significant artefact to images)
- Must be fit for general anesthesia or regional anesthesia as assessed by the
consultant anesthetist
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior androgen suppression therapy
- No prior radiotherapy for prostate cancer
- No prior chemotherapy for prostate cancer
- No prior significant rectal surgery preventing insertion of transrectal probe
- No prior transurethral resection of the prostate or laser prostatectomy
- No prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave
therapy to the prostate
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Feasibility
Safety Issue:
No
Principal Investigator
Mark Emberton, MD, FRCS, MBBS
Investigator Role:
Study Chair
Investigator Affiliation:
University College London Hospitals
Authority:
Unspecified
Study ID:
CDR0000574367
NCT ID:
NCT00561262
Start Date:
May 2006
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
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