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clinical trials |
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Novel Treatments of Prostate CancerAn important goal of the Prostate Cancer Program is to develop novel treatments of prostate cancer. We have initiated a number of pre-clinical studies and clinical trials for prostate cancer. Pre-clinical studies are focusing on immunotherapeutic as well as gene therapy techniques. We are testing tumor associated antigens, DNA vaccines and blockading the immune surveillance system as potential means of treating prostate cancer. Novel gene therapy protocols are being developed with the Sodium Iodide symporter gene. Karla Ballman, Ph.D., and Eugene Kwon, M.D., studied the early effects of pharmacological androgen deprivation in human prostate cancer. They showed that pharmacological androgen deprivation therapy induces significant involution within prostatic tissues over 7-28 days, but allows the persistence of some viable tumor cells capable of proliferation. Eric Bergstralh, M.S.; Bradley Leibovich, M.D.; and Michael Blute, M.D.; studied obesity and survival after radical prostatectomy in a 10-year prospective cohort. Body-Mass Index (BMI) appears to influence prostate cancer outcomes at the time of prostatectomy, as evidenced by more aggressive pathologic features. However, after prostatectomy, BMI does not appear to be an independent predictor of recurrence or survival. Dr. Blute and statistician Bergstralh studied the impact of familial and hereditary prostate cancer on cancer specific survival after radical retropubic prostatectomy. They concluded that, except for preoperative serum prostate specific antigen level, clinicopathological features and long-term oncological outcomes are equivalent after radical prostatectomy in patients with familial, hereditary and sporadic prostate cancer. Prostate Cancer Program researchers further this type of research by conducting clinical trials to determine the safety and effectiveness of new therapies or new uses for available drugs. For example: Thomas Pisansky, M.D., is conducting two Phase III clinical trials trying to determine the relative effectiveness of 3D-conformal radiation therapy/intensity modulated radiation therapy high dose versus standard dose for patients with localized prostate cancer, as well as hypofractionated versus conventionally fractionated for patients with favorable risk prostate cancer. Brian Davis, M.D., Ph.D., has an open Phase III study comparing combined external beam radiation and transperineal interstitial permanent brachytherapy with brachytherapy alone for selected patients with intermediate risk prostate carcinoma. Patrick Burch, M.D., is evaluating a novel therapeutic with patients who were in the placebo arm of the original immunotherapy trial and experienced disease progression and disease-related pain. Dr. Burch is also conducting a Phase II trial of Halichondrin B analog in patients with metastatic hormone refractory prostate cancer, as well as two Phase III clinical trials, evaluating androgen ablation versus chemo-hormonal therapy for extensive disease and intermittent androgen deprivation for patients with Stage D2 prostate cancer. He also is conducting research designed to improve quality-of-life issues, including managing a trial evaluating early versus standard zoledronic acid to prevent skeletal-related events in men with prostate cancer metastatic to bone. Another quality-of-life study, one that capitalizes on the many collaborations, both intra- and inter-institutional, of the Prostate Cancer Program has been conducted by Ajay Nehra, M.D. He is looking at the efficacy and safety study of toremifene citrate for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy. Ronald Richardson, M.D., is conducting a Phase III trial comparing docetaxel and prednisone with and without bevacizumab in men with hormone refractory prostate cancer. Eugene Kwon, M.D., is determining whether combination androgen ablative therapy and CTLA-4 blockade may be a treatment option for advanced prostate cancer. Michael Lieber, M.D., is conducting a long-term follow up study of the Prostate Cancer Prevention Trial (PCPT) for men diagnosed with prostate cancer. |
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