Prostate Cancer
Conditions
Keywords
hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine
Brief summary
This is a prospective phase II trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.
Interventions
DRUGdocetaxel and samarium
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years and less than 80 years * Histologically-proven adenocarcinoma of the prostate * Evidence of bone metastases and progressive, hormone-refractory, disease * No previous chemotherapy * No previous radiotherapy, except radiotherapy directed to the prostate and/or to a single bony lesion * No previous carcinoma, except basal-cell carcinoma of the skin * Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min * Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value * Signed informed consent.
Exclusion criteria
* Patients infected by the Human Immunodeficiency Virus (HIV) * Patients who do not fit inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate specific antigen (PSA) response rate | — |
| Toxicity | — |
| Overall survival | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORKarim Fizazi, Dr
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed