Clinical trial NCT00561262: High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer
Official title: An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-20
Enrollment: 60
Sex: MALE
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue.

PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized prostate cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Feasibility
measure: Adverse events
measure: Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function
measure: Side effect profile
Secondary outcomes:
measure: Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir
measure: Exclusion of cancer on MRI at 2-7 days and at 6 months
measure: Transrectal ultrasound biopsies at 6 months
measure: Need for secondary or adjuvant treatment for prostate cancer following therapy
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
Study officials:
affiliation: University College London Hospitals
name: Mark Emberton, MD, FRCS, MBBS
role: STUDY_CHAIR
References:
citation: Ahmed HU, Freeman A, Kirkham A, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localized prostate cancer: a phase I/II trial. J Urol. 2011 Apr;185(4):1246-54. doi: 10.1016/j.juro.2010.11.079. Epub 2011 Feb 22.