Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Scandinavian Prostate Cancer Group
With
Sanofi
Primary endpoint:
* PSA progression rate, ASTRO guidelines.
Secondary endpoints:
* PSA doubling time after progression
* Quality of Life (QoL)
* Safety
* Metastases free survival
* Overall survival
Age
18–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy
