Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
- Patients must have clinical stage 1-3 disease and no radiographic evidence of
- Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of
being free from biochemical progression at 5 years after surgery of <60%.
- 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.
Type of Study:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Pathological Complete Response.
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
Outcome Time Frame:
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.
Jacqueline Vuky, MD
Virginia Mason Medical Center
United States: Food and Drug Administration
- Prostate Cancer
- Prostatic Neoplasms
|Virginia Mason Medical Center
||Seattle, Washington 98111