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

NCT00823771 | Terminated

• 1 other identifier: ALCC 07.01
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires

  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

Study Arms (2)

Reviewed by radiation oncologist

Reviewed by general practitioner

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barwon Health: lead

Study Sites (1)

Andrew Love Cancer Centre

Geelong, Victoria, 3220, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rodney Lynch, BMedSc, MBBS

  Barwon Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: October 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2014
• Last Updated: February 2, 2017

Record last verified: 2013-02

Locations

AU (1)