Men, 18-70 years old, who have had radical prostatectomy due to prostate cancer and with a high grade pT3 or margin positive pT2 tumour may be candidates for the study.
Conditions
Interventions
Trade Name: Taxotere
Pharmaceutical Form:
Sponsors
Scandinavian prostate cancer group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: *Men > 18 and =70 years of age. *WHO/ECOG performance status 0 – 1. *Histologically proven adenocarcinoma of the prostate. *Either of the following: - pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen or - any pT3 tumour with Gleason score 4+3 or higher. *If pre-operative PSA =10.0 ng/ml, lymph node dissection should be performed. *Post-operative PSA = 0.5 ng/ml. *Adequate haematological-, liver- and kidney function. *Negative bone scan prior to study start. *Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *M+ (Positive bone scan indicating spread of tumour). *N+ (Known positive lymph nodes at histological examination). *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 hormonal manipulation (e.g. LHRH analogues and/or antiandrogens) affecting prostate cancer cells. *Previous radiotherapy to pelvic region. *Previous chemotherapy. *Systemic corticosteroids within 6 months prior to randomisation. *Unstable cardiovascular disease within 6 months prior to randomisation. *Active untreated infectious disease. *Active gastric ulcer. *Known hypersensitivity to Polysorbate 80. *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 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PSA progression after adjuvant Taxotere treatment compared to surveillance after radical prostatectomy .;Secondary Objective: PSA doubling time Overall survival Metastasis free survival Quality of life;Primary end point(s): PSA =0.5 ng/ml | — |
Countries
Denmark, Finland, Iceland, Sweden
Outcome results
None listed