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

NCT00987675 | Unknown Phase 2

• 2 other identifiers: CDR0000650138UCLH-09-H0714-7
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: High-intensity focused ultrasound 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 ablation and to see how well it works in treating patients with progressive prostate cancer.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months

Secondary Outcomes (3)

• Success of treatment as demonstrated by the absence of cancer at 6 months

• PSA kinetics after completion of treatment

• Proportion of patients requiring androgen blockade at 12 months

Interventions

pharmacological study 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 on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria: * Stage ≤ T3b, N0, M0 disease * Gleason score ≤ 8 * Serum PSA ≤ 20 ng/mL * No metastatic disease and nodal spread by staging CT or MRI * Negative bone scan within the past 6 months * Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI * Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved PATIENT CHARACTERISTICS: * Able to tolerate a transrectal ultrasound * Able to undergo major surgery as assessed by a consultant anesthesiologist * Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant) * No urethral stricture or presence of metal implants or stents in the urethra * No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy * No allergy to latex PRIOR CONCURRENT THERAPY: * No prior radiotherapy * No prior treatment with any of the following: * Transurethral resection of the prostate or equivalent procedures within the past 2 years * High-intensity focused ultrasound ablation (HIFU) * Cryosurgery * Thermal or microwave therapy to the prostate * No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe * More than 12 months since prior androgen suppression or hormone treatment for prostate cancer

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, England, WIT 3AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

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

• Hashim Uddinn Ahmed, MD

  University College London Hospitals

Study Design

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

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Last Updated: August 26, 2013

Record last verified: 2011-03

Locations

GB (1)