Prostate Cancer Clinical Trial
Official title:
A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
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:
1. To evaluate medium term cancer control using histological parameters. Stage two of INDEX
will evaluate conversion to radical and systemic therapies and link men to national
databases to determine survival in 5 and 10 years.
2. To confirm that focal therapy can lead to low rates of genitourinary and rectal toxicity
and minimal impact on quality of life within a large and more representative cohort of
patients (greater precision around outcome measures).
3. To demonstrate that the skills (characterization through template prostate mapping and
MRI as well as the treatment related skills) acquired by the team at UCLH are indeed
transferable to other providers.
4. To calculate costs of care and to model potential cost-effectiveness in comparison to
alternative therapies. If this single arm intervention study demonstrates acceptable
outcomes to support the findings of the Phase I/II studies, it is anticipated that this
preliminary study will lead onto a Phase III evaluation of focal therapy, prior to more
widespread use of this technology.
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