A Pilot Study to Assess the Follow-up of Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment (PROFUGO)
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ClinicalTrials.gov Identifier: NCT00823771
(Data review showed that the study was underpowered to draw clear conlcusions)
This is a pilot study assessing the role of the general practitioner in performing follow-up reviews on men who have recently completed radical radiotherapy for prostate cancer. This will be measured primarily by assessing any changes to the patient's health-related quality of life which will be evaluated by the completion of questionnaires by the participant at each review visit. The study aims to confirm that patient outcome is identical, independent of whether follow-up is performed by a specialist or the patient's General Practitioner.
To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires [ Time Frame: QOL questionnaires will be asked to be completed at baseline, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months ]
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men approximately six months post-completion of radical radiotherapy treatment for prostate cancer who have not experienced significant treatment toxicities or disease progression.
Men with a tumour T1-3 stage prostate cancer and have had radical radiotherapy with curative intent
Are between six and twelve months post-treatment completion
Have completed all treatment for prostate cancer (including hormonal deprivation therapy)
Have no evidence of metastatic disease
ECOG performance status of between 0-1
Remains willing to comply with study requirements
Has maintained contact with an individual general practitioner
Persistent complications resulting from treatment defined as a minimum Grade 3 treatment toxicity
Unable to complete self-administered questionnaires
Are currently enrolled in a study that requires specialist follow-up