Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000538640
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiation sensitivity in prostate cancer patients
Scientific title
Radiation sensitivity in prostate cancer patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 665 0
Condition category
Condition code
Cancer 738 738 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nil
Intervention code [1] 652 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 912 0
1. To determine whether increased in vitro sensitivity to radiation-induced DNA damage in lymphocytes is a predictor of prostate cancer risk.
Timepoint [1] 912 0
Primary outcome [2] 913 0
2. To develop a set of biomarkers that predict the risk of abnormal tissue reaction to radiotherapy in prostate cancer patients.
Timepoint [2] 913 0
Primary outcome [3] 914 0
3. To identify dietary and genetic factors that have a strong modifying effect on the risk of abnormal tissue reaction to radiotherapy.
Timepoint [3] 914 0
Secondary outcome [1] 1768 0
1. To determine whether increased in vitro sensitivity to radiation-induced DNA damage in lymphocytes is a predictor of prostate cancer risk.
Timepoint [1] 1768 0
Secondary outcome [2] 1769 0
2. To develop a set of biomarkers that predict the risk of abnormal tissue reaction to radiotherapy in prostate cancer patients.
Timepoint [2] 1769 0
Secondary outcome [3] 1770 0
3. To identify dietary and genetic factors that have a strong modifying effect on the risk of abnormal tissue reaction to radiotherapy.
Timepoint [3] 1770 0

Eligibility
Key inclusion criteria
The first stage of the project is a case-control study involving 100 untreated Prostate cancer cases and 100 controls. Cases and controls will be matched for age, gender, familial history of cancer and smoking status.The second stage of the project is a prospective study aimed at determining whether the selected biomarkers predict abnormal tissue reaction in 100 localized Prostate cancer patients treated with RT who have ECOG 0-2 performance status and do not have a constant requirement for aperients or anti-diarrhoeal medication. Age, weight, tumour grade, family history of prostate cancer, use of anti-male hormone therapy and smoking status will be recorded.
Minimum age
Not stated
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/12/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 819 0
Other
Name [1] 819 0
Country [1] 819 0
Primary sponsor type
Hospital
Name
ROYAL ADELAIDE HOSPITAL
Address
Country
Australia
Secondary sponsor category [1] 685 0
Government body
Name [1] 685 0
CSIRO
Address [1] 685 0
Country [1] 685 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2086 0
ROYAL ADELAIDE HOSPITAL
Ethics committee address [1] 2086 0
Ethics committee country [1] 2086 0
Australia
Date submitted for ethics approval [1] 2086 0
Approval date [1] 2086 0
Ethics approval number [1] 2086 0

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

Contacts
Principal investigator
Name 36375 0
Address 36375 0
Country 36375 0
Phone 36375 0
Fax 36375 0
Email 36375 0
Contact person for public queries
Name 9841 0
Dr Eric Yeoh, MD FRCP (EDIN) FRCR
Address 9841 0
Radiation Oncology
Royal Adelaide Hospital (RAH) Cancer Centre
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 9841 0
Australia
Phone 9841 0
+61 8 82224000
Fax 9841 0
Email 9841 0
eyeoh@mail.rah.sa.gov.au
Contact person for scientific queries
Name 769 0
Julie Butters
Address 769 0
Radiation Oncology
Royal Adelaide Hospital (RAH) Cancer Centre
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 769 0
Australia
Phone 769 0
+61 8 82224378
Fax 769 0
Email 769 0
jbutters@mail.rah.sa.gov.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.