Prostate Cancer Clinical Trial
— INDEXOfficial title:
A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
Verified date | April 2018 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 354 |
Est. completion date | June 2029 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London | London | England |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | rate of erectile dysfunction | The presence of severe erectile dysfunction at 12 months, as measured by the IIEF-5 questionnaire with or without the use of phosphodiesterase-5 inhibitors, in those with absence of severe erectile dysfunction at baseline | 12 months | |
Secondary | rate of erectile dysfunction | The presence of severe erectile dysfunction at 24 months, as measured by the IIEF-5 questionnaire with or without the use of phosphodiesterase-5 inhibitors, in those with absence of severe erectile dysfunction at baseline | 24 months | |
Secondary | time to return of erectile function | Time to return of erectile function (absence of severe ED on IIEF-15 questionnaire) | 24 months | |
Secondary | rate of urinary incontinence (pad free, leak free and pad-free alone) | Presence of urinary incontinence (any pad usage plus any leakage of urine) as determined by the UCLA-EPIC urinary continence questionnaire, at 12 months, in those men with no urinary incontinence at baseline | 12 months | |
Secondary | rate of urinary incontinence (pad free, leak free and pad-free alone) | Presence of urinary incontinence (any pad usage plus any leakage of urine) as determined by the UCLA-EPIC urinary continence questionnaire, at 24 months, in those men with no urinary incontinence at baseline | 24 months | |
Secondary | time to return of continence (pad free, leak free and pad-free alone) | Time to return of urinary continence (as determined by UCLA-EPIC Urinary domain questionnaire) | 24 months | |
Secondary | rate of loss of ejaculation | rate of loss of ejaculation (as determined by IIEF-15 questionnaire) | 24 months | |
Secondary | rate of loss of orgasm | rate of loss of orgasm (as determined by IIEF-15 questionnaire) | 24 months | |
Secondary | rate of pain during intercourse | rate of pain during intercourse (as determined by IIEF-15 questionnaire) | 24 months | |
Secondary | number of men using phosphodiesterase-5 inhibitors to maintain erectile function | Need for phosphodiesterase-5 inhibitors to maintain erectile function sufficient for penetration up to 24 months | 24 months | |
Secondary | rate of lower urinary tract symptoms | Grading of lower urinary tract symptoms as determined by IPSS scores | 24 months | |
Secondary | rate of bowel toxicity | UCLA-EPIC Bowel Function Questionnaire | 24 months | |
Secondary | anxiety levels | EQ-5D Quality of Life Questionnaire | 24 months | |
Secondary | general health related quality of life | General and prostate health related quality of life measured using EQ-5D Quality of Life questionnaire | 24 months | |
Secondary | proportion of men achieving trifecta status at 12 months | Achievement of trifecta status (no severe ED, pad-free leak-free continence, cancer control with absence of clinically significant cancer) at 12 months in those men with good baseline function | 12months | |
Secondary | proportion of men achieving trifecta status at 24 months | Achievement of trifecta status (no severe ED, pad-free leak-free continence, cancer control with absence of clinically significant cancer) at 24 months in those men with good baseline function | 24 months | |
Secondary | rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation, whole-gland HIFU or cryosurgery) | rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation, whole-gland HIFU or cryosurgery) | 24 months | |
Secondary | risk factors for failure defined as a) presence of any cancer and b) clinically significant cancer at study end | risk factors for failure defined as a) presence of any cancer and b) clinically significant | 24 months | |
Secondary | biochemical (PSA) kinetics including determining the optimal biochemical definition of failure | biochemical (PSA) kinetics including determining the optimal biochemical definition of | 24 months | |
Secondary | describe composite outcomes of failure | describe composite outcomes of failure | 24 months | |
Secondary | Cost-effectiveness | To determine the costs of treatment and model potential cost effectiveness using comparative cancer control and functional outcomes at 5 years compared to other cohort trials involving the management of localized prostate cancer | 5years | |
Secondary | Cost-effectiveness | To determine the costs of treatment and model potential cost effectiveness using comparative cancer control and functional outcomes at 10 years compared to other cohort trials involving the management of localized prostate cancer | 10 years |
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