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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Participants will receive standard prostate IMRT of 74Gy in 37 fractions delivered over 7.5 weeks.
Participants will receive prostate and pelvis IMRT with a dose of 74Gy in 37 fractions delivered over 7.5 weeks to the prostate and 60Gy in 37 fractions delivered over 7.5weeks to the pelvis.
Queen Elizabeth
Birmingham, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Hospital
Cardiff, United Kingdom
Ipswich
Ipswich, United Kingdom
Clatterbridge Centre for Oncology
Liverpool, United Kingdom
Royal Marsden NHSFT
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Acute lower GI RTOG toxicity at week 18 of follow-up.
Proportion of patients with acute GI RTOG grade ≥2 toxicity at week 18 from start of radiotherapy calculated as the number of patients with grade ≥2 toxicity at week 18 over the number of evaluable at week 18.
Time frame: 18 weeks post treatment
Ability to deliver 60Gy in 37 fractions to the pelvis using the varying radiotherapy planning techniques and delivery systems at the participating centres.
Time frame: 2 yr
Late (1 and 2 year) toxicity
Measured using RTOG toxicity scale and CTCAE
Time frame: 2 yr
Patient Reported Outcomes
Participants are requested to complete questionnaires to record the impact of the treatments on bowel and bladder function.
Time frame: 2 yr
Biochemical progression free survival
Time frame: 10 yr
Time to local progression
Time frame: 10 yr
Time to distant metastases
Time frame: 10 yr
Overall survival
Time frame: 10 yr
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