Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Wednesday 29th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00823771
Ethics application status
Date submitted
14/01/2009
Date registered
14/01/2009
Date last updated
31/01/2017

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
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 -

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
Primary outcome [2] 0 0
To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires
Timepoint [2] 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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other
Name
Barwon Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00823771
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00823771