Prostate Cancer
Conditions
Keywords
Advanced Prostate Cancer, HRPC, Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy, Taxotere, Docetaxel, Prednisone, Vaccine, Allogeneic cells
Brief summary
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
Interventions
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
DRUGChemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
Sponsors
Cell Genesys
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate * Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy * Detectable metastases * ECOG performance status ≤2 (Performance status of 3 if due to bone pain) * Any Gleason score * Only one prior treatment with systemic chemotherapy * No prior treatment with gene therapy * No prior immunotherapy for prostate cancer * Taxane naïve * Experiencing cancer-related pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | 0 |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression. Time to pain progression. | 0 |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Sweden, United Kingdom, United States
Outcome results
None listed