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

NCT ID: NCT00823771

Last Updated: 2017-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2014-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Reviewed by radiation oncologist

No interventions assigned to this group

Reviewed by general practitioner

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Barwon Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodney Lynch, BMedSc, MBBS

Role: PRINCIPAL_INVESTIGATOR

Barwon Health

Locations

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Andrew Love Cancer Centre

Geelong, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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ALCC 07.01

Identifier Type: -

Identifier Source: org_study_id

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