CLINICAL TRIAL: PHASE II STUDY TO ASSESS RADIATION AND DOCETAXEL IN PROSTATE CAN

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: Primary Objective: To determine the rate of PSA decline and the number of subjects reaching a PSA nadir of zero following local irradiation combined with docetaxel chemotherapy followed by four courses of docetaxel in men with hormone-naive prostate cancer who fail to achieve a PSA nadir of zero following radical prostatectomy. Secondary Objectives: To confirm the tolerability of this regimen, the proression free survival based on PSA progression, the overall survival of subjects and if the velocity of subsequent PSA failure impacts on survival. Tertiary Objectives: To document subsequent therapy for failing patients and if there is a response to that therapy. RESEARCH PLAN: Patient will receive seven cycles of 20 mg/m2/week (over one hour) of docetaxel during irradiation. Then docetaxel 75 gm/m2 IV (over one hour) every 21 days for four cycles. The intial dose of Radiation will be 4500 cGY. With the final boost, the total dose will be 6840-6900 cGy (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions. METHODS: The data will be analyzed on an intent-to-treat basis. Descriptive statistics for demographic and baseline characteristics will be summarized for both continuous and categorical variables. The primary endpoint will be summarized, and further analyzed, using logistic regression to assess the impact of baseline characteristics such as demographics, velocity of PSA prior to surgery, etc. For the secondary endpoints, the Kaplan-Meier survival method will be used. In addition, the Cox regression will be used to assess if the velocity of subsequent PSA failure and other variables impact on survival. CLINICAL RELEVANCE: Patients with a persistent PSA after RRP are ideal patients to study with early chemotherapy. They clearly have persistent disease, but it is not bulky enough to be overt. There is no question, unless they die of something else, these men are destined to have progressive, metastatic prostate cancer. In this group of patients, it will be readily apparent whether chemotherapy is effective in curing prostate cancer. This finding would be on the par with treating high risk breast cancer patients where an additional 10% are cured if given adjuvant chemotherapy.