High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 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:
NCT00561262
First received: November 17, 2007
Last updated: February 18, 2011
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Other: questionnaire administration Procedure: high-intensity focused ultrasound ablation Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | An Evaluation of Hemi-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 [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: No ]
- Side effect profile [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir [ Designated as safety issue: No ]
- Exclusion of cancer on MRI at 2-7 days and at 6 months [ Designated as safety issue: No ]
- Transrectal ultrasound biopsies at 6 months [ Designated as safety issue: No ]
- Need for secondary or adjuvant treatment for prostate cancer following therapy [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 79 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561262
Locations
| United Kingdom | |
| 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: | NCT00561262 History of Changes |
| Other Study ID Numbers: | CDR0000574367, UCLCTC-UCLH-HEMI-HIFU, EU-20774, ISRCTN25145525 |
| Study First Received: | November 17, 2007 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013