Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benaroya Research Institute
• Collaborators: Cell Genesys; Sanofi
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease

• Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of <60%.

Exclusion Criteria:

• Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms)

• Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment.

• Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.