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

This study has been terminated.
(Data review showed that the study was underpowered to draw clear conlcusions)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823771
First Posted: January 16, 2009
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Barwon Health
  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:


Further study details as provided by Barwon Health:

Primary Outcome Measures:
  • To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires [ Time Frame: 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 ]

Enrollment: 107
Study Start Date: October 2007
Study Completion Date: April 1, 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Reviewed by radiation oncologist
Reviewed by general practitioner

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823771


Locations
Australia, Victoria
Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3220
Sponsors and Collaborators
Barwon Health
Investigators
Principal Investigator: Rodney Lynch, BMedSc, MBBS Barwon Health
  More Information

Responsible Party: Barwon Health
ClinicalTrials.gov Identifier: NCT00823771     History of Changes
Other Study ID Numbers: ALCC 07.01
First Submitted: January 14, 2009
First Posted: January 16, 2009
Last Update Posted: February 2, 2017
Last Verified: February 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases