High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University College London Hospitals
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00561314
First received: November 17, 2007
Last updated: February 18, 2011
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Sexual Dysfunction and Infertility Urinary Incontinence |
Other: questionnaire administration Procedure: biopsy Procedure: high-intensity focused ultrasound ablation Procedure: magnetic resonance imaging Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events [ Designated as safety issue: Yes ]
- Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ... [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ... [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | July 2007 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate.
Secondary
- To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy.
OUTLINE: A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients are then evaluated over a 12-month period.
Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also undergo transrectal ultrasound biopsy at 6 months to evaluate disease response.
Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate erectile and sexual function, urinary flow and continence, and quality-of-life.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Low-risk disease, as defined by the following criteria:
- Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
- Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
- Serum PSA ≤ 15 ng/mL
- Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
- Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
- All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
- No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
- No metastatic disease
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 5 years
- Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
- No prior rectal fistula
- No American Society of Anesthesiology grades III-IV
- No latex allergies
- No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
- No moderate to severe inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
- No androgen suppression treatment within the past 6 months
- No transurethral resection of the prostate or laser prostatectomy within the past 5 years
- No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
- No prior significant rectal surgery preventing insertion of transrectal probe
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561314
Locations
| United Kingdom | |
| Basingstoke and North Hampshire NHS Foundation Trust | Recruiting |
| Basingstoke, England, United Kingdom, RG24 9NA | |
| Contact: Contact Person 44-1256-313-556 richard.hindley@bnhft.nhs.uk | |
| University College of London Hospitals | Recruiting |
| London, England, United Kingdom, WIT 3AA | |
| Contact: Contact Person 44-207-380-9194 | |
Sponsors and Collaborators
University College London Hospitals
Investigators
| Study Chair: | Mark Emberton, MD, FRCS, MBBS | University College London Hospitals |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00561314 History of Changes |
| Other Study ID Numbers: | CDR0000574344, UCLCTC-UCLH-FOCAL-HIFU, EU-20773 |
| Study First Received: | November 17, 2007 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
sexual dysfunction and infertility urinary incontinence adenocarcinoma of the prostate |
stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer |
Additional relevant MeSH terms:
|
Sexual Dysfunctions, Psychological Adenocarcinoma Prostatic Neoplasms Infertility Urinary Incontinence Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases Genital Diseases, Female Sexual and Gender Disorders Mental Disorders Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013