Prostate cancer prostate carcinoma
Conditions
Interventions
Arm A: Antiandrogen alone (bicalutamide 150 mg x 1)
Arm B: Antiandrogen (bicalutamide 150 mg x 1) + docetaxel (Taxotere®) 75mg/m2
(max. 2.0 m2) i.v. in 60 minutes on day 1. One cycle is 21 days. Doce
Sponsors
Scandinavian Prostate Cancer Group
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Men > 18 and 10 OR PSA DT 0.5 (PSA doubling time calculation must start at a minimum value of > 0.5) o Radiation: PSA > +2.0 above nadir and PSA >10 OR PSA DT 0.5. (PSA bouncing after radiotherapy should be excluded according to the local traditions, and PSA doubling time calculation must start at a minimum value of > 0.5) · In locally advanced (or local not suitable for curative therapy) prostate cancer patients, PSA 20 or o Gleason score 8-10, - Previous hormonal therapy in conjunction with radiotherapy is allowed, provided that the total duration of therapy does not exceed 12 months and has to be stopped > 12 months ago. - Testosterone value > 5 nmol/l - Adequate haematological-, liver- and kidney function. - Negative bone scan performed no more than 3 months prior to randomisation. - Additional CT or ultrasound of thorax, abdomen and/or pelvis is optional - Written informed consent.
Exclusion criteria
Exclusion criteria: - Positive Bone scan. - Any distant metastasis detected by CT or ultrasound. - 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 5 years. - Previous chemotherapy or randomised in SPCG 12/AdPro or SPCG 13/AdRad. - 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. - Symptomatic peripheral neuropathy >= CTCAE grade 2. - Patients who by altered physical or psychological state not are able to co-operate or participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare progression free survival (PFS) between the two treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare · Metastasis free survival · Cancer specific survival · Overall survival · Quality of Life (QoL) · PSA doubling time after progression | — |
Countries
Netherlands
Outcome results
None listed