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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:
081748
ACTR Number:
ACTRN12607000097448
Trial Status:
Registered
Date Submitted:
23/12/2003
Date Registered:
23/12/2003
Page 1
Public title:
A randomised trial investigating the effect on biomedical (PSA) control and survival of different durations of adjuvant androgen deprivation in association with definite radiation treatment for localised carcinoma of the prostate (RADAR)
Update:
Reason:
ANZCTR registration title:
Trans Tasman Radiation Oncology Group (TROG) 03.04 - A randomised trial investigating the effect on biomedical (Prostate Specific Antigen- PSA) control and survival of different durations of adjuvant androgen (Leuprorelin acetate and zoledronic acid)deprivation in association with definite radiation treatment for localised carcinoma of the prostate (The RADAR trial)
Update:
Reason:
Secondary ID 1:
National Clinical Trials Registry: NCTR491
Secondary ID 2:
ClinicalTrials.gov: NCT 00193856
UTN:
Update:
Reason:
Trial acronym:
TROG 03.04 - RADAR
Update:
Page 2
Health condition(s) or problem(s) studied:
Localised carcinoma of the prostate
Condition category:
Condition code:
Cancer
Prostate
Page 3
Description of intervention(s) / exposure:
Androgen deprivation: artificial drugs create a depression in the production of sex hormones. Arm A: Androgen deprivation (AD): 6 months Luteinising Hormone - Releasing Hormone (LH-RH) analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months, at 0 and 3 months. Radiation begins after 5 months AD. Arm B: Androgen deprivation: 6 months LH-RH analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months, at 0 and 3 months. Radiation begins after 5 months AD. Bisphosphonate therapy (Zoledronic acid 4mg) every 3 months for 18 months by IV. Arm C: Androgen deprivation: 18 months LH-RH analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months at 0, 3, 6, 9, 12 and 15 months. Radiation treatment begins after 5 months AD. Arm D: Andorgen deprivation: 18 months LH-RH analogue (Leuprorelin acetate 22.5mg) depot injected every 3 months at 0, 3, 6, 9, 12 and 15 months. Radiation treatment begins after 5 months AD. Bisphosphonate therapy (Zoledronic acid 4mg) every 3 months for 18 months by IV. Radiation will be 66Gy in 33 fractions of 2gy in all cases for a period of 8 weeks.
Update:
Reason:
Intervention code:
Treatment: drugs
Comparator / control treatment:
LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 mths)
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Reason:
Control group:
Active
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Reason:
Page 4
Primary outcome:
Prostate Specifc Antigen (PSA) relapse free survival. Measured until a biochemical relapse or death from any cause.
Timepoint:
Follow up is 3 monthly for 1 year. Then 6 monthly for 5 years post randomisation and then annually until death.
Secondary outcome 1:
1. Overall survival.
Timepoint:
Measured until a death from any cause. Follow up is 3 monthly for 1 year. Then 6 monthly for 5 years post ransomisation and then annually until death.
Secondary outcome 2:
2. Clinical, local and bony relapse free survival and associated patterns of failure.
Timepoint:
Measured until bone metastasis, distant relapse, local relapse, rising PSA, or death from any cuase. Follow up is 3 monthly for 1 year. Then 6 monthly for 5 years post ransomisation and then annually until death.
Secondary outcome 3:
3. Changes in bone mineral density and osteopenic features.
Timepoint:
Measured until death. Follow up is 3 monthly for 1 year. Then 6 monthly for 5 years post ransomisation and then annually until death.
Secondary outcome 4:
4. Quality of life self assessment.
Timepoint:
Performed at baseline, 3 months, 12, 18 and 24 months.
Page 5
Key inclusion criteria:
Histological confirmation of adenocarcinoma of the prostate in the three months prior to randomisation- Gleason primary and secondary pattern reported. If the volume of tumour in biopsies is too small for the pathologist to allocate a secondary pattern, the primary pattern alone is sufficient.- Primary tumour stage T2b - 4 (UICC 2002), or T2a providing biopsies demonstrate Gleason score 7 or more, and presenting PSA 10 or more- PSA value obtained within one month of randomisation- No evidence of lymphatic or haematogenous metastases, as determined by negative chest x-ray, CT scan of abdomen and pelvis, and bone scan in the 3 months prior to randomisation- ECOG performance status 0 - 1- No concurrent medical conditions likely to significantly reduce prospects of 5 year survival- Patient accessible to follow up at intervals specified in protocol- Written informed consent given (signed by both patient and investigator prior to randomisation)
Update:
Reason:
Minimum Age:
18
Years
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Reason:
Maximum Age:
No limit
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Reason:
Gender:
Males
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Reason:
Healthy volunteers?
No
Update:
Reason:
Key exclusion criteria:
Previous or concurrent malignancy within previous 5 years except for non-melanomatous skin cancer- Prostatectomy- Prior pelvic radiotherapy- Prior hormone treatment for prostate cancer- Inability to complete self administered QOL questionnaire- Prior bisphosphonate therapy- Serum creatinine > 2 x ULN- Osteoporosis resulting in >30% loss in vertebral height in one or more thoraco-lumbar vertebrae- Liver disease resulting in ALT or AST levels >3 x ULN- Prolonged continuous glucocorticoid therapy > 10 mg/day of prednisone equivalent (>6 months)- Current treatment with bisphosphonate
Update:
Reason:
Page 6
Study type:
Interventional
Update:
Reason:
Purpose of the study:
Treatment
Update:
Allocation to intervention:
Randomised controlled trial
Update:
Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
central randomisation by phone /computer
Update:
Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Stratified allocation. Factors: Treatment centre, presenting Prostate Specific Antigen, gleason score, stage. Simple randomisation by computer.
Update:
Reason:
Masking / blinding:
Open (masking not used)
Update:
Reason:
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Assignment:
Factorial
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Reason:
Other design features (specify):
Update:
Reason:
Type of endpoint(s):
Safety/efficacy
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Reason:
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Page 7
Phase
Phase 3
Update:
Reason:
Anticipated or actual date of first participant enrolement:
23/10/2003
Update:
Reason:
Target sample size:
1000
Update:
Reason:
Recruitment status:
Closed: follow-up continuing
Update:
Reason:
Page 8
Funding source 1:
Government funding body e.g. Australian Research Council
Name:
National Health & Medical Research Council Project Grant
Address:
Level 5, 20 Allara St Canberra ACT 2601
Country:
Australia
Funding source 2:
Government funding body e.g. Australian Research Council
Name:
Health Research Council New Zealand
Address:
PO Box 5541, Wellesley Street, Auckland
Country:
New Zealand
Primary sponsor:
Individual
Update:
Reason:
Name:
Jim Denham
Update:
Reason:
Address:
Edith St Waratah NSW 2298
Update:
Reason:
Country:
Australia
Update:
Reason:
Secondary sponsor:
Other Collaborative groups
Name:
Trans Tasman Radiation Oncology Group (TROG)
Address:
Edith St Waratah NSW 2298
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee:
Countries of recruitment:
Australia
Brief summary:
Six months of hormone treatment improves the results of radiotherapy for men with early prostate cancer. This trial will determine if adding another 12 months of hormone treatment after radiotherapy is even better. Bones are often affected by prostate cancer and can also be damaged by prolong hormone treatment. Bisphosphonates are drugs that make bones stronger. This trial will also determine if treatment with a bisphosphonate can help prevent these bone problems.
Update:
Reason:
Trial website:
Update:
Presentations / publication list:
Update:
Page 10
Contact person for public queries
Name:
Jean Ball
Update:
Reason:
Address:
Waratah Post Office, Turton Road Waratah, NSW
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 2 4985 4011
Update:
Reason:
Fax:
N/A
Update:
Reason:
Email:
jean.Ball@newcastle.edu.au
Update:
Reason:
Contact person for scientific queries
Name:
Jim Denham
Update:
Reason:
Address:
Waratah Post Office, Turton Road Waratah, NSW
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 2 4985 4018
Update:
Reason:
Fax:
N/A
Update:
Reason:
Email:
Jim.Denham@newcastle.edu.au
Update:
Reason:
Contact person responsible for updating information
Name:
Erin Nolan
Update:
Reason:
Address:
Department of Radiation Oncology Locked Bag 7 Hunter Region Mail Centre NSW 2310
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 2 4014 3912
Update:
Reason:
Fax:
+61 2 4014 3902
Update:
Reason:
Email:
Erin.Nolan@trog.com.au
Update:
Reason:
