Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00823771




Registration number
NCT00823771
Ethics application status
Date submitted
14/01/2009
Date registered
16/01/2009
Date last updated
2/02/2017

Titles & IDs
Public title
A Pilot Study to Assess the Follow-up of Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment
Scientific title
A Pilot Study in the Transfer of Follow-up Reviews to the General Practitioner for Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment
Secondary ID [1] 0 0
ALCC 07.01
Universal Trial Number (UTN)
Trial acronym
PROFUGO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Reviewed by radiation oncologist -

Reviewed by general practitioner -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires
Timepoint [1] 0 0
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

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Andrew Love Cancer Centre - Geelong
Recruitment postcode(s) [1] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Government body
Name
Barwon Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rodney Lynch, BMedSc, MBBS
Address 0 0
Barwon Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00823771