Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

000768

ACTR Number:

ACTRN12605000538640

Trial Status:

Registered

Date Submitted:

20/09/2005

Date Registered:

28/09/2005

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Public title:

Radiation sensitivity in prostate cancer patients

ANZCTR registration title:

Radiation sensitivity in prostate cancer patients

Secondary ID:

UTN:

Trial acronym:

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Health condition(s) or problem(s) studied:
Prostate Cancer

Cancer	Prostate
Condition category:	Condition code:

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Description of intervention(s) / exposure:

Nil

Intervention code:

Comparator / control treatment:

Control group:

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

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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

Gender:

Males

Healthy volunteers?

Key exclusion criteria:

No exclusion criteria

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Study type:

Observational

Purpose:

Screening

Duration:

Longitudinal

Selection:

Defined population

Timing:

Both

Page 7

Phase

Phase 1

Anticipated or actual date of first participant enrolement:

23/12/2003

Target sample size:

100

Recruitment status:

Open to recruitment

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Funding source:

Other

Name:

Address:

Country:

Primary sponsor:

Hospital

Name:

ROYAL ADELAIDE HOSPITAL

Address:

Country:

Australia

Secondary sponsor:

Government funding body e.g. Department of Health

Name:

CSIRO

Address:

Country:

Australia

Other collaborator:

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Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name:

ROYAL ADELAIDE HOSPITAL

Address:

Country:

Australia

Date of approval:

HREC Number:

Countries of recruitment:

Australia

Brief summary:

Trial website:

Presentations / publication list:

Page 10

Contact person for public queries

Name:

Dr Eric Yeoh, MD FRCP (EDIN) FRCR

Address:

Radiation Oncology Royal Adelaide Hospital (RAH) Cancer Centre Royal Adelaide Hospital North Terrace Adelaide SA 5000

Country:

Australia

Tel:

+61 8 82224000

Fax:

Email:

eyeoh@mail.rah.sa.gov.au

Contact person for scientific queries

Name:

Julie Butters

Address:

Radiation Oncology Royal Adelaide Hospital (RAH) Cancer Centre Royal Adelaide Hospital North Terrace Adelaide SA 5000

Country:

Australia

Tel:

+61 8 82224378

Fax:

Email:

jbutters@mail.rah.sa.gov.au

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

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