Status:
COMPLETED
RADAR Trial - Randomised Androgen Deprivation and Radiotherapy
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Hunter Medical Research Institute (HMRI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The principal objectives of the RADAR trial is to address the hypotheses; 1) that 18 months androgen deprivation in conjunction with radiotherapy is superior to 6 months androgen deprivation prior to ...
Detailed Description
Traditionally androgen deprivation (by orchidectomy, or more recently by medication) has been reserved for the palliative treatment of men with advanced, incurable prostate cancer. However, evidence f...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- Inability to attend for follow-up at the Investigator's clinic
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
1071 Patients enrolled
Trial Details
Trial ID
NCT00193856
Start Date
October 1 2003
End Date
August 1 2017
Last Update
October 12 2017
Active Locations (24)
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1
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
2
St George Hospital
Kogarah, New South Wales, Australia, 2217
3
Lismore Hospital
Lismore, New South Wales, Australia, 2480
4
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871