Prostate Cancer
Conditions
Keywords
Adjuvant treatment, high risk, radical radiotherapy
Brief summary
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
Detailed description
Primary endpoint: * PSA progression rate, ASTRO guidelines. Secondary endpoints: * PSA doubling time after progression * Quality of Life (QoL) * Safety * Metastases free survival * Overall survival
Interventions
DRUGdocetaxel
docetaxel 75 mg/square meter i.v. every third week, six cycles
Sponsors
Scandinavian Prostate Cancer Group
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men \> 18 and ≤75 years of age. * WHO/ECOG performance status 0 - 1. * Histological proven adenocarcinoma of the prostate within 12 months prior to randomisation * One of the following: * T2 with Gleason score 7(4+3 ) and PSA \>10 ng/ml to \< 70 ng/ml * T2 with Gleason 8-10, any PSA \< 70 ng/ml * any T3 tumour * Prior neoadjuvant hormone therapy is mandatory for all patients * Adequate haematological-, liver- and kidney function. (Hemoglobin \> 110 g/l, neutrophils \> 1.5 x 109/ l, platelets \> 150 x 109/ l, ASAT and ALAT \< 1.5 x ULN, ALP \< 1.5 x ULN, creatinine \< 1.5 x ULN) * Written informed consent
Exclusion criteria
* M+ * N+ clinical or pathological * Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years. * Previous radiotherapy to the pelvic region. * Previous chemotherapy within 5 years. * Systemic corticosteroids within 6 months prior to randomisation. * Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation. * Active untreated infectious disease, including tuberculosis, MRSA. * Active gastric ulcer. * Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel) * Other serious illness or medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA progression rate | From randomization to progression | According to RTOG-ASTRO guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival | From randomisation to year 2014 | PSA doubling measured, FACT-P, detection of metastatic lesions |
Countries
Norway
Outcome results
None listed