Intermediate or high-risk prostate cancer treated with radical radiotherapy MedDRA version: 8.1 Level: PT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: DOCETAXEL
Sponsors
Scandinavian Prostate Cancer Group/ P.O. Hedlund
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. > 18 and =75 years of age 2. Radical radiotherapy for prostate cancer 3. WHO/ECOG performance status 0 – 1 4. Histologically proven adenocarcinoma of the prostate within 9 months prior to randomisation. 5. One of the following: T2 with Gleason 7 (4+3) and PSA >10 ng/ml T2 with Gleason 8-10, any PSA any T3 tumours. 6. Prior neoadjuvant hormone therapy is mandatory for all patients 7. Adequate haematological-, liver- and kidney function (less than 1.5 x UNL for creatinine, less than 1.5 X UNL for liver laboratory values except bil =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. M+ 2. N+ 3. 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. 4. Previous radiotherapy to pelvic region. 5. Previous chemotherapy within five years. 6. Systemic corticosteroids within 6 months prior to randomisation. 7. Unstable cardiovascular disease within 6 months prior to randomisation. 8. Active untreated infectious disease. 9. Active gastric ulcer. 10. Known hypersensitivity to Polysorbate 80. 11. Other serious illness or medical condition. 12. Symptomatic peripheral neuropathy = CTCAE grade 2. 13. 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: Primary objective: time to PSA progression;Secondary Objective: Secondary objectives: PSA doubling time, Quality of Life (QoL), Safety, Metastases free survival, Overall survival.;Primary end point(s): Compare time to PSA progression in intermediate or high-risk prostate cancer patients between chemotherapy+ hormonal treatment versus hormonal treatment alone | — |
Countries
Finland, Ireland, Sweden
Outcome results
None listed