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

This study has suspended participant recruitment.
(Met target accrual, suspended for data review.)
Sponsor:
Information provided by (Responsible Party):
Barwon Health
ClinicalTrials.gov Identifier:
NCT00823771
First received: January 14, 2009
Last updated: February 12, 2014
Last verified: February 2013
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: October 2007
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: February 12, 2014
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 September 18, 2014