As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance
Primary endpoint: * PSA progression rate, ASTRO guidelines. Secondary endpoints: * PSA doubling time after progression * Quality of Life (QoL) * Safety * Metastases free survival * Overall survival
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
378
docetaxel 75 mg/square meter i.v. every third week, six cycles
Jon R Iversen
Oslo, Norway
PSA progression rate
According to RTOG-ASTRO guidelines
Time frame: From randomization to progression
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
PSA doubling measured, FACT-P, detection of metastatic lesions
Time frame: From randomisation to year 2014
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