High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer

NCT00561314 | Completed Phase 2

• 3 other identifiers: CDR0000574344UCLCTC-UCLH-FOCAL-HIFUEU-20773
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer; Sexual Dysfunction; Urinary Incontinence

Keywords

sexual dysfunction; urinary incontinence; adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events

• 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 ...

Secondary Outcomes (1)

• 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 ...

Interventions

questionnaire administration OTHER

biopsy PROCEDURE

high-intensity focused ultrasound ablation PROCEDURE

magnetic resonance imaging PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (2)

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Related Publications (1)

• Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17.

  PMID: 22512844 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunction, Physiological; Urinary Incontinence

Interventions

Biopsy; High-Intensity Focused Ultrasound Ablation; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Mark Emberton, MD, FRCS, MBBS

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2007
• First Posted: November 20, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: January 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2009-07

Locations

GB (2)