Prostate Cancer Clinical Trial
Phase III clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy.
Primary objective: To study the difference in quality of life in relation to anti-androgen
versus total androgen blockage.
Exploratory parameters: ▪ Time to PSA relapse
- Time to symptom giving metastasis
- Overall survival
Patients with localized /locally advanced prostate cancer were subject to treatment with
curative intention. They could be divided into three groups according to the risk of
metastasis. Mainly intermediate risk group of patients were included in this study. Patients
with low risk could be included if they were subject to neo-adjuvant hormonal therapy.
Different risk groups were defined as below:
Low risk group: PSA ≤10 ng/ml Gleason score ≤ 6 Tumour stage ≤ T2b Intermediate risk group:
Presence of 1-2 factors of high risk. High risk group: PSA >10 ng/ml Gleason score ≥7 Tumour
stage T2c - T3b
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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