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

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT00577356

Run by

Benaroya Research Institute

People needed

6

Starts

2008-02-01

Expected to finish

2008-09-01

Last updated by the study team

2011-01-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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.

Where it is running

• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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