Focal Therapy for Prostate Cancer Using HIFU

NCT01194648 | Recruiting

• 2 other identifiers: CDR00006840209945
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Prospective trials using hemi-ablation with high intensity focused ultrasound (HIFU) (Sonablate 500) have demonstrated feasibility, safety, and encouraging functional outcomes and early cancer control with 90% of men achieving trifecta status (no erectile dysfunction, leak-free pad-free continence, cancer control). However, these trials have involved small numbers of patients with men selected for good baseline function. A multi-centre prospective trial within a larger cohort of men that better represents the patient population with prostate cancer (external validity) is required.

Conditions

Male Erectile Disorder; Prostate Cancer; Therapy-related Toxicity; Urinary Incontinence

Keywords

urinary incontinence; male erectile disorder; therapy-related toxicity; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (2)

• Conversion to radical therapy and/or requiring systemic therapy and/or developing metastases and/or dying of prostate cancer

  To determine the proportion of men converting to radical therapy and/or requiring systemic therapy and/or developing metastases and/or dying of prostate cancer following focal therapy for localised prostate cancer using HIFU

  5 years

• Conversion to radical therapy and/or requiring systemic therapy and/or developing metastases and/or dying of prostate cancer

  To determine the proportion of men converting to radical therapy and/or requiring systemic therapy and/or developing metastases and/or dying of prostate cancer following focal therapy for localised prostate cancer using HIFU

  10 years

Secondary Outcomes (22)

• rate of erectile dysfunction

  12 months

• rate of erectile dysfunction

  24 months

• time to return of erectile function

  24 months

• rate of urinary incontinence (pad free, leak free and pad-free alone)

  12 months

• rate of urinary incontinence (pad free, leak free and pad-free alone)

  24 months

Study Arms (1)

High Intensity Focused Ultrasound

OTHER

HIFU, the Intervention

Other: questionnaire administration; Procedure: assessment of therapy complications; Procedure: high-intensity focused ultrasound ablation; Procedure: multiparametric magnetic resonance imaging; Procedure: quality-of-life assessment; Procedure: transperineal prostate biopsy; Procedure: transrectal prostate biopsy

Interventions

questionnaire administration OTHER

High Intensity Focused Ultrasound

assessment of therapy complications PROCEDURE

High Intensity Focused Ultrasound

high-intensity focused ultrasound ablation PROCEDURE

High Intensity Focused Ultrasound

multiparametric magnetic resonance imaging PROCEDURE

High Intensity Focused Ultrasound

quality-of-life assessment PROCEDURE

High Intensity Focused Ultrasound

transperineal prostate biopsy PROCEDURE

High Intensity Focused Ultrasound

transrectal prostate biopsy PROCEDURE

High Intensity Focused Ultrasound

Eligibility Criteria

• Age: Up to 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

1. Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies. 2. Prostate biopsy (either TRUS or MRI Targeted or Template): * TRUS biopsy: up to burden bilateral disease with maximum 3mm one biopsy on non-dominant side is allowable. * MRI targeted and/or Template biopsy within 12 months of entry showing: * unilateral disease minimum 3mm of Gleason 3+3 or any Gleason 3+4 or 4+3 but not exceeding Gleason 4+3 overall OR * bilateral disease presence of clinically significant cancer on only one side (as determined by histological rules described above) Gleason ≤7 which is concordant with the MRI findings. 3. Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted). 4. Serum PSA \</=20ng/ml 5. Life expectancy of \>/=10 years. 6. Signed informed consent by patient. 7. An understanding of the English language sufficient to understand

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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, England, WC1E 6BT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Neoplasms; Urinary Incontinence

Interventions

High-Intensity Focused Ultrasound Ablation

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic 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)

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

Study Officials

• Mark Emberton, MD, FRCS, MBBS

  University College, London

  STUDY CHAIR

• Hashim Uddinn Ahmed, MD, FRCS

  Imperial College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-Centre Prospective Single Arm Intervention Trial

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: June 29, 2011
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

GB (1)