None listed
Conditions
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.
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 therap
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.
Sponsors
Trans Tasman Radiation Oncology Group (TROG)
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed