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

Prostate Cancer Clinical Trial

— PROFUGO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00823771
• Other study ID #: ALCC 07.01
• Status: Terminated
• Phase: N/A
• First received: January 14, 2009
• Last updated: January 31, 2017
• Start date: October 2007
• Est. completion date: April 1, 2014

Study information

• Verified date: February 2013
• Source: Barwon Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: April 1, 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Australia	Andrew Love Cancer Centre	Geelong	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Barwon Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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