Prostate CancerPROFUGONCT00823771
A Pilot Study to Assess the Follow-up of Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment
An observational study of Prostate Cancer, run by Barwon Health at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 107 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2007to 1 Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Reviewed by radiation oncologist | Not described | |
| Reviewed by general practitioner | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2012
- Study completion1 Apr 2014
Why it stopped: Data review showed that the study was underpowered to draw clear conlcusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barwon Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rodney Lynch, BMedSc, MBBS, Principal investigator, Barwon Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823771
- Sponsor's protocol ID
- ALCC 07.01
- Acronym
- PROFUGO
- Status last verified
- Feb 2013
- First submitted
- 14 Jan 2009
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00823771
- Acronym / sponsor ID
- PROFUGO / ALCC 07.01
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data review showed that the study was underpowered to draw clear conlcusions
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Barwon HealthOther government
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reviewed by radiation oncologist | – | – |
| Reviewed by general practitioner | – | – |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Data review showed that the study was underpowered to draw clear conlcusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney Lynch, BMedSc, MBBS principal investigator
Barwon Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Barwon Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Data review showed that the study was underpowered to draw clear conlcusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.