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)
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)
Trans Tasman Radiation Oncology Group (TROG)
1,000 participants
Oct 23, 2003
Interventional
Conditions
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.
Eligibility
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Interventions
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.
Locations(1)
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ACTRN12607000097448