Title (CALGB 90203) A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer -
Principal Investigator James Mohler, MD
Study Number 100607
The purpose of this study is to determine whether treatment with chemotherapy and hormonal therapy prior to prostate surgery will increase progression free survival compared to treatment with immediate prostate surgery alone for high risk prostate cancer patients (patients with a predicted chance of cure with surgery at 15 years follow-up of <60%). Patients will be randomized into one of two groups. Group 1 will be treated with chemotherapy and hormone therapy for approximately 4 months prior to surgery. In group 2, patients will be treated immediately with surgery alone.
- Histologic documentation of prostatic adenocarcinoma.
- No evidence of metastatic disease.
- Patients must have a Kattan nomogram predicted probability of being disease free 5 years after surgery of less than 60% or a Gleason sum greater than or equal to 8.
- No prior treatment for prostatic adenocarinoma.
- Patients must be appropriate candidates for radical prostatectomy.
- ECOG performance status 0-2.
- Greater than or equal to 18 years of age.