Prostate Cancer Clinical Trial
Official title:
A Randomised Phase II Trial of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer
Prostate cancer is the most common male cancer in the UK with 35,000 cases diagnosed
annually. 35% of these are locally advanced disease. These patients have a high chance of
pelvic lymph node involvement and have relatively poor prostate cancer survival rates of
22.5% at 10 years.
One of the standard treatments for these patients is radiotherapy to the prostate. PIVOTAL is
a multi-centre phase II non-comparative randomised feasibility trial, in which patients with
a high chance of pelvic lymph node involvement are randomised between prostate radiotherapy
alone and prostate + pelvic radiotherapy.
Both groups will receive radiotherapy called Intensity Modulated Radiation Therapy (IMRT).
This is a relatively new method of shaping radiotherapy treatment beams which allows the
tumour to be treated more precisely, whilst avoiding more of the surrounding normal, healthy
tissues (particularly the rectum, bladder and bowel). Using IMRT, it is possible to deliver
higher doses of radiotherapy to the pelvis than with previous radiotherapy methods - this has
been tested in a single hospital, single group setting and levels of side effects (toxicity)
were acceptable.
PIVOTAL aims to find out whether toxicity levels at 18 weeks from the start of radiotherapy
remain acceptable when treatment is given in multiple cancer centres across the UK. It is
randomised to ensure unbiased collection of acute toxicity data and to provide information on
patients' willingness to participate in a randomised study. Should the phase II study be
successful, the investigators would develop a phase III trial to compare treatment
effectiveness (disease control).
Patients who enter PIVOTAL will be followed up for two years from the start of radiotherapy
and data relating to toxicity will be collected. They will also be asked to complete patient
related symptoms questionnaires. Data related to disease recurrence will then be collected
annually from patients' standard hospital visits.
n/a
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