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

A Pilot Study in the Transfer of Follow-up Reviews to the General Practitioner for Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00823771

Acronym

PROFUGO

Enrollment

107

Registered

2009-01-16

Start date

2007-10-31

Completion date

2014-04-01

Last updated

2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Australia

Outcome results