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

Phase 2

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00577356
• Lead Sponsor: Benaroya Research Institute

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-20
• Study Start: 2008-02
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2010-09-13
• Status Verified: 2010-11
• Results First Submitted QC: 2011-01-18
• Last Update Submitted: 2011-01-18
• Results First Posted: 2011-01-20
• Last Update Posted: 2011-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pathological Complete Response.	The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.	CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States