Trial Information
A Pilot Study in the Transfer of Follow-up Reviews to the General Practitioner for Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires
Outcome 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
Safety Issue:
No
Principal Investigator
Rodney Lynch, BMedSc, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barwon Health
Authority:
Australia: Human Research Ethics Committee
Study ID:
ALCC 07.01
NCT ID:
NCT00823771
Start Date:
October 2007
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms