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

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00823771
• Lead Sponsor: Barwon Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-16
• Primary Completion: 2012-10
• Status Verified: 2013-02
• Study Completion: 2014-04-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 107

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires	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

Trial Locations

Locations (1)

Andrew Love Cancer Centre; 🇦🇺 Geelong, Victoria, Australia