RADAR Trial - Randomised Androgen Deprivation and Radiotherapy
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen Deprivation, Hormone Therapy, RadiotherapyBisphosphonate, Prostate Specific Antigen (PSA)
Eligibility Criteria
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) 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 Inability to attend for follow-up at the Investigator's clinic
Sites / Locations
- Campbelltown Hospital
- St George Hospital
- Lismore Hospital
- Liverpool Hospital
- Calvary Mater Newcastle
- Nepean Cancer Care Centre
- Royal North Shore Hospital
- Riverina Cancer Care Centre
- Westmead Hospital
- Illawarra Cancer Care Centre
- Royal Brisbane Hospital
- Mater QRI
- John Flynn Private Hospital
- Princess Alexandra Hospital
- Launceston General Hospital
- Peter MacCallum Cancer Centre
- Andrew Love Cancer Care Centre, Geelong Hospital
- Sir Charles Gairdner Hospital
- Auckland Hospital
- Christchurch Hospital
- Dunedin Hospital
- Waikato Hospital
- Palmerston North Hospital
- Wellington Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Experimental
A
B
C
D
LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 mths)
LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 months) + bisphosphonate therapy.
LH-RH analogue as for arm A, but continued for further 12 months (total 18 months)
LH-RH analogue as for arm A, but continued for further 12 months (total 18 months) + bisphosphonate therapy.