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

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

This study is currently recruiting participants.

Verified August 2011 by Barwon Health

First Received on January 14, 2009. Last Updated on August 23, 2011 History of Changes

Sponsor:	Barwon Health
Information provided by (Responsible Party):	Barwon Health
ClinicalTrials.gov Identifier:	NCT00823771

Purpose

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.

Condition
Prostate Cancer

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Barwon Health:

Estimated Enrollment:	112
Study Start Date:	October 2007

Groups/Cohorts
Reviewed by radiation oncologist
Reviewed by general practitioner

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Men approximately six months post-completion of radical radiotherapy treatment for prostate cancer who have not experienced significant treatment toxicities or disease progression.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823771

Contacts

Contact: Elaine Yeow, BSc, MHN

61-3-52267858

elainey@barwonhealth.org.au

Locations

Australia, Victoria
Andrew Love Cancer Centre	Recruiting
Geelong, Victoria, Australia, 3220
Contact: Elaine Yeow 61-3-52267858
Principal Investigator: Rodney Lynch, BMedSc, MBBS

Sponsors and Collaborators

Barwon Health

Investigators

Principal Investigator:

Rodney Lynch, BMedSc, MBBS

Barwon Health

More Information

No publications provided

Responsible Party:	Barwon Health
ClinicalTrials.gov Identifier:	NCT00823771 History of Changes
Other Study ID Numbers:	ALCC 07.01
Study First Received:	January 14, 2009
Last Updated:	August 23, 2011
Health Authority:	Australia: Human Research Ethics Committee

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012