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

NCT00988130 | Unknown Phase 2

• 3 other identifiers: CDR0000652331UCL-09-H0714-7EU-20977
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells. PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.

Conditions

Prostate Cancer; Sexual Dysfunction

Keywords

sexual dysfunction; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (2)

• Total proportion of men with erectile dysfunction and/or incontinence

• Quality of life

Secondary Outcomes (3)

• Success of index lesion ablation with HIFU at 6 months

• Prostate-specific antigen kinetics

• Proportion of men requiring androgen blockade at 12 months

Interventions

laboratory biomarker analysis OTHER

questionnaire administration OTHER

assessment of therapy complications PROCEDURE

high-intensity focused ultrasound ablation PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies * Stage ≤ T3bN0M0 * Gleason grade ≤ 8 * Serum PSA ≤ 20 ng/mL * Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease * No metastatic disease and/or nodal spread by CT scan or MRI * Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI * No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy PATIENT CHARACTERISTICS: * Able to tolerate a transrectal ultrasound * Not allergic to latex * Fit for major surgery as assessed by a consultant anaesthetist * Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.) PRIOR CONCURRENT THERAPY: * No prior radiotherapy * No androgen suppression and/or hormone treatment within the past 12 months * No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases) * No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years * No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate

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 (1)

University College Hospital - London

London, England, WIT 3AA, United Kingdom

RECRUITING

Related Publications (1)

• Ahmed HU, Dickinson L, Charman S, Weir S, McCartan N, Hindley RG, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study. Eur Urol. 2015 Dec;68(6):927-36. doi: 10.1016/j.eururo.2015.01.030. Epub 2015 Feb 11.

  PMID: 25682339 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunction, Physiological

Interventions

High-Intensity Focused Ultrasound Ablation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mark Emberton, MD, FRCS, MBBS

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: July 1, 2009
• Last Updated: August 26, 2013

Record last verified: 2011-05

Locations

GB (1)