This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.
This study will look at the safety of curative radiotherapy to the prostate and lymph glands given in 5 visits, in men with high risk localised prostate cancer. The purpose of the research is to test an advanced type of external beam radiotherapy called stereotactic body radiotherapy (also known as SBRT) in 1128 participants with high risk localised prostate cancer (that is, prostate cancer that has not spread beyond the prostate gland but is at high risk of growing quickly or spreading). Importantly, this treatment delivers a potentially curative dose of radiotherapy in only 5 treatments over two weeks. Half the participants in the trial will receive radiotherapy to the prostate, the other half will have radiotherapy to the prostate as well as the surrounding lymph nodes. The investigators will follow patients in the trial for at least three and half years to see which treatment is best. The investigators will be looking at whether it is safe to give this treatment by reviewing any side-effects that occur and also assessing whether giving SBRT to the lymph nodes as well as the prostate reduces the chance of prostate cancer returning. The treatment will take place at NHS radiotherapy centres that are experienced in giving SBRT and radiotherapy to the pelvic nodes, and have been quality assured to deliver these treatments
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,128
Stereotactic Body Radiotherapy
Time to biochemical or clinical failure
Time to biochemical or clinical failure as defined by time from randomisation to the first progression event (either biochemical failure, local recurrence, lymph node/pelvic recurrence, distant metastases, recommencement of androgen deprivation therapy or death due to prostate cancer).
Time frame: minimum of 3.5 years follow up post-randomisation
Clinical reported acute toxicity
Clinical reported acute and late toxicity using CTCAE version 5.0 and RTOG criteria. Focus will be given to GU and GI Grade 2 or higher (G2+) toxicities
Time frame: 12 weeks post-randomisation
Clinical reported late toxicity
Clinical reported acute and late toxicity using CTCAE version 5.0 and RTOG criteria. Focus will be given to GU and GI Grade 2 or higher (G2+) toxicities
Time frame: up to 5 years post-randomisation
Metastatic relapse-free survival
Time from randomisation to distant metastases or death from prostate cancer
Time frame: up to 5 years post-randomisation
Prostate cancer-specific survival
Time from randomisation to death due to prostate cancer
Time frame: up to 5 years post-randomisation
Overall survival
Time from randomisation to death from any cause
Time frame: up to 5 years post-randomisation
Patient Reported Outcome Measures
Quality of life will be evaluated using combined data from the following questionnaires. IPSS questionnaire: a validated diagnostic tool used to assess urinary \& bowel incontinence. IIEF-5: validated diagnostic tool for erectile dysfunction. EPIC questionnaire: to assess typical symptoms after radiotherapy in prostate cancer patients. EQ-5D: a commonly used generic questionnaire to measure health-related QoL used to asess mobility, self-care, usual activities, pain/discomfort, anxiety/depression \& the subject's perceptions of their own current overall health. A QoL analysis plan will be developed in consultation with the TMG with key endpoints for each questionnaire. Standard algorithms will be used to derive scores and handle missing data. Changes from baseline at each time point will be compared within groups as well as between treatment groups (by means of ordinal logistic regressions or ANCOVA models). Analyses to account for the longitudinal nature of the data may be used.
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Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre
Cork, Ireland
RECRUITINGSt Lukes Radiation Oncology Network
Dublin, Ireland
RECRUITINGMid Western Radiation Oncology Centre
Limerick, Ireland
RECRUITINGAuckland Hospital
Auckland, New Zealand
NOT_YET_RECRUITINGJames Cook University Hospital
Middlesbrough, South Tees, United Kingdom
RECRUITINGWorcestershire Acute Hospitals Nhs Trust
Worcester, Worcestershire, United Kingdom
RECRUITINGBelfast City Hospital
Belfast, United Kingdom
RECRUITINGBristol Haematology and Oncology Centre
Bristol, United Kingdom
RECRUITINGWest Suffolk NHS Foundation Trust
Bury St Edmunds, United Kingdom
RECRUITINGAddenbrookes Hospital
Cambridge, United Kingdom
RECRUITING...and 32 more locations
Time frame: up to 5 years post-randomisation
Adherence to radiotherapy protocol
Qualitative analysis of adherence to pre-specified radiotherapy dose constraints with radiotherapy quality assurance to demonstrate feasibility in a muliticentre setting.
Time frame: after completion of treatment