RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Male

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 and during radiotherapy; 2) that 18 months Bisphosphonate therapy will prevent bone loss caused by androgen deprivation therapy and further reduce relapse risk by impeding the development of bony metastases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborators: Abbott; Calvary Mater Newcastle, Australia; Cancer Society of New Zealand; Health Research Council, New Zealand; Hunter Medical Research Institute (HMRI); Maitland Cancer Appeal; National Health and Medical Research Council, Australia; Novartis Pharmaceuticals; University of Newcastle, Australia
• Treatments: Androgens; Diphosphonates; Leuprolide; Zoledronic Acid

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