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

Benaroya Research Institute

Status and phase

Terminated

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Docetaxel

Biological: CG1940/CG8711

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00577356

IRB07028

IST# 16194

I-0057

Details and patient eligibility

About

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).

Enrollment

6 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.