An interventional study of questionnaire administration and assessment of therapy complications in Male Erectile Disorder, Prostate Cancer and Therapy-related Toxicity, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to male participants aged Up to 90 Years. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
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.
Verification of a new therapy as favourable, or equivalent, in outcome to 'standard' care is ideally sought through comparison with another matched control group. Randomised controlled trials (RCTs) offer the best method for minimising systematic bias and revealing the true effect of an intervention or drug. However, RCTs involving treatments of localised prostate cancer have had a historically poor patient uptake, as the reference 'gold' standard of care is not known. In addition, RCTs are expensive to run and involve huge infra-structural support. A number of trials in the USA have been forced to close due to lack of recruitment. The ProStart trial in the UK has also had to close for the same reason. It has been acknowledged by the Food and Drug Agency in the USA that comparative randomized trials will be problematic in this area due to lack of physician and patient equipoise. A randomized trial may be feasible if a pragmatic design is adopted but prior to acceptance of such a design, the number of centres with expertise in this complex intervention (mp-MRI, TTPM, focal HIFU) will need to be increased.
Observational studies are a commonly used alternative to ascertain the effectiveness of a treatment. They are used to observe a treatment effect in a selected group of patients who are presumed to derive benefit from the treatment given. Although methodologically not as robust, and therefore prone to bias, they have some benefits over RCTs. The principal ones are those of enhanced external validity (many patients do not wished to be randomised and therefore refuse participation), and more rapid accrual compared to a randomised design. For this reasons, a single arm medium term follow-up cohort intervention study has been designed. At the time of writing the safety and tolerability aspects of focal therapy by HIFU are known as a result of the Phase I/II studies carried out at UCLH. The results have been presented and exist in the public domain in abstract form but have not yet been published (presented in tables above). These early studies were powered to detect a change in the proportion of men who could obtain an erection sufficient for penetration compared to their status prior to their treatment. The very low event rate for both erectile dysfunction and incontinence indicates that the 'proof of concept' has been demonstrated for focal therapy. Moreover, we can be relatively confident that, in expert hands, focal HIFU is safe. Therefore, a multi-centre study is now required involving a larger group of patients for the following reasons:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 354 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Prostate biopsy (either TRUS or MRI Targeted or Template):
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
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
Time frame: 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
Time frame: 10 years
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
Time frame: 12 months
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
Time frame: 24 months
time to return of erectile function
Time to return of erectile function (absence of severe ED on IIEF-15 questionnaire)
Time frame: 24 months
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
Time frame: 12 months
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
Time frame: 24 months
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)
Time frame: 24 months
rate of loss of ejaculation
rate of loss of ejaculation (as determined by IIEF-15 questionnaire)
Time frame: 24 months
rate of loss of orgasm
rate of loss of orgasm (as determined by IIEF-15 questionnaire)
Time frame: 24 months
rate of pain during intercourse
rate of pain during intercourse (as determined by IIEF-15 questionnaire)
Time frame: 24 months
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
Time frame: 24 months
rate of lower urinary tract symptoms
Grading of lower urinary tract symptoms as determined by IPSS scores
Time frame: 24 months
rate of bowel toxicity
UCLA-EPIC Bowel Function Questionnaire
Time frame: 24 months
anxiety levels
EQ-5D Quality of Life Questionnaire
Time frame: 24 months
general health related quality of life
General and prostate health related quality of life measured using EQ-5D Quality of Life questionnaire
Time frame: 24 months
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
Time frame: 12months
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
Time frame: 24 months
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)
Time frame: 24 months
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
Time frame: 24 months
biochemical (PSA) kinetics including determining the optimal biochemical definition of failure
biochemical (PSA) kinetics including determining the optimal biochemical definition of
Time frame: 24 months
describe composite outcomes of failure
describe composite outcomes of failure
Time frame: 24 months
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
Time frame: 5years
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
Time frame: 10 years
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University College, London