None listed
Conditions
Brief summary
This trial is designed primarily to determine whether maximal androgen deprivation, prior to and during radiation therapy, reduces the rate of local failure and appearance of metastases that takes place after radiation therapy. A secondary aim is to determine whether a short period of androgen deprivation (3 months) is as effective as a longer period (6 months). A tertiary aim to see whether the tumour shrinkage caused by androgen deprivation prior to radiation therapy leads to any noticeable reduction in the long-term side-effects of subsequent radiation therapy. By defining the tolerability of and compliance with the regimens used, the final objective is to determine whether androgen deprivation as produced in this study is applicable for widespread use outside of the randomised clinical trial setting.
Interventions
Arm A: Maximal androgen deprivation for 2 months prior to and during radiation therapy (total 3 months) Arm B: Maximal androgen deprivation for 5 months prior to and during radiation therapy (total 6 months).
Androgen Deprivation: Zoladex 3.6 mg monthly (every 29 days Sub cutaneous); Eulexin (Flutamide) 250 mg orally three times a day, for either - Two months prior to the commencement of radiation therapy and for one month during radiation therapy (ie 3 months total) or Five months prior to the
Arm A: Maximal androgen deprivation for 2 months prior to and during radiation therapy (total 3 months) Arm B: Maximal androgen deprivation for 5 months prior to and during radiation therapy (total 6 months). Androgen Deprivation: Zoladex 3.6 mg monthly (every 29 days Sub cutaneous); Eulexin (Flutamide) 250 mg orally three times a day, for either - Two months prior to the commencement of radiation therapy and for one month during radiation therapy (ie 3 months total) or Five months prior to the commencement of radiation therapy and for one month during radiation therapy (ie 6 months total).
Sponsors
Trans Tasman Radiation Oncology Group (TROG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients will be those with histologically confirmed, locally advanced adenocarcinoma of the prostate. Included will be patients with primary tumours confined to but diffusely involving more than half of the prostate (clinical stage T2b, c [B2]) or extending beyond the capsule (clinical stage T3, 4 [C]). Patients without regional lymph node involvement demonstrable on CT scan, lymphography or pelvic node sampling- Performance status must be equal to or less than ECOG 1- Eligible patients should be willing to accept the side-effects of maximal androgen deprivation therapy as defined herein- All institutional and ethical guidelines must be followed and all patients must sign an informed consent prior to being placed in the study.
Exclusion criteria
Stage T1 or T2a (A or B1) disease- Evidence of distant metastases- Lymph node involvement, either clinically, radiologically or pathologically- Radical surgery for carcinoma of the prostate, previous radiation, hormonal manipulation or chemotherapy- Previous or concurrent cancers other than non-melanomatous skin cancer- Major intercurrent physical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment or adequate follow-up either through disablement or limitation of life expectancy to less than 1 year- Performance status of greater than 1 on the ECOG scale
Outcome results
None listed