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Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Pathological Complete Response.

Outcome Description:

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.

Safety Issue:

Yes

Principal Investigator

Jacqueline Vuky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Mason Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

IRB07028

NCT ID:

NCT00577356

Start Date:

February 2008

Completion Date:

September 2008

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Virginia Mason Medical CenterSeattle, Washington  98111