A Pilot Study to Assess the Follow-up of Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment (PROFUGO)

Barwon Health

Status: Terminated

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00823771

ALCC 07.01

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Life expectancy of less than 6 months
• Surgery to remove the prostate
• Evidence of biochemical failure

Trial design

107 participants in 2 patient groups

Reviewed by radiation oncologist

Reviewed by general practitioner