24 Prostate Cancer 1 1 0 19 19 183 http://clinicaltrials.dfhcc.harvard.edu/trials/183 Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 3 248 http://clinicaltrials.dfhcc.harvard.edu/trials/248 Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 3 332 http://clinicaltrials.dfhcc.harvard.edu/trials/332 Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising PSA After Surgery for Prostate Cancer RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 3 426 http://clinicaltrials.dfhcc.harvard.edu/trials/426 Observation or Radical Treatment in Patients With Prostate Cancer RATIONALE: Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. Radical treatments, such as radical prostatectomy or radiation therapy, may be effective in treating prostate cancer when it is first diagnosed. It is not yet known whether observation is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer. PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 3 1301 http://clinicaltrials.dfhcc.harvard.edu/trials/1301 Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 3 1423 http://clinicaltrials.dfhcc.harvard.edu/trials/1423 Study of Immunotherapy to Treat Advanced Prostate Cancer The purpose of the study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 3 135 http://clinicaltrials.dfhcc.harvard.edu/trials/135 Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors The purpose of this study is to discover if intensive lifestyle changes (such as diet and increased physical activity) improve the body's sensitivity to insulin, and therefore help prevent diabetes and other cardiovascular disease, in men receiving GnRH hormone therapy for prostate cancer. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 2 162 http://clinicaltrials.dfhcc.harvard.edu/trials/162 Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases). Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 2 279 http://clinicaltrials.dfhcc.harvard.edu/trials/279 Avastin, Docetaxel and Androgen Deprivation Followed by Continued Avastin and Androgen Deprivation for Men With a Rising PSA After Local Therapy In this research study, we are looking to see how Avastin works in combination with docetaxel and hormone therapy for men who have a rising PSA after treatment of their prostate cancer with surgery or radiation. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 2 310 http://clinicaltrials.dfhcc.harvard.edu/trials/310 RAD001 and Bicalutamide for Androgen Independent Prostate Cancer The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In addition, several hundred kidney and heart transplant patients have been treated with the same main ingredient as in RAD001 for many years. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 2 153 http://clinicaltrials.dfhcc.harvard.edu/trials/153 Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer The purpose of this research study is to determine the effects of abiraterone acetate plus leuprolide acetate and prednisone versus leuprolide acetate alone on hormone levels in the blood and prostate. For this study, patients are required to be suitable candidates for a radical prostatectomy (prostate surgery) which will be performed after 24 weeks of treatment. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 2 1286 http://clinicaltrials.dfhcc.harvard.edu/trials/1286 Ketoconazole, Hydrocortisone, Dutasteride and Lapatanib (KHAD-L) in Prostate Cancer The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone adn dutasteride (KHAD) with lapatanib. The investigators believe that there is evidence in castrate resistant prostate cancer that two growth factor receptors (EGFr and Her 2 /neu )are increased in prostate cancer cells. Both these receptors are turned off by the drug lapatanib. By adding lapatanib to this trial, the investigators hope that the investigators can turn off the signaling from the receptors and therefore make the participant's cancer more responsive to KHAD treatment. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer Phase 1/Phase 2 65 http://clinicaltrials.dfhcc.harvard.edu/trials/65 A Phase 1b Study of MDX-1106 in Subjects With Advanced or Recurrent Malignancies The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer 16 Melanoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/16-melanoma 10 Kidney Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/10-kidney-cancer 13 Lung Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/13-lung-cancer Phase 1 84 http://clinicaltrials.dfhcc.harvard.edu/trials/84 Personal Patient Profile Prostate (P4) Randomized, Multisite Trial The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant. Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes. About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer N/A 214 http://clinicaltrials.dfhcc.harvard.edu/trials/214 Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of prostate cancer. PURPOSE: This randomized clinical trial is studying polyunsaturated fatty acids in treating patients with prostate cancer undergoing prostate biopsy and/or surgery. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer N/A 1217 http://clinicaltrials.dfhcc.harvard.edu/trials/1217 Sunitinib Plus Prednisone In Patients With Metastatic Hormone-Refractory Prostate Cancer After Failure Of Docetaxel Chemotherapy This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic hormone-refractory prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer 1234 http://clinicaltrials.dfhcc.harvard.edu/trials/1234 Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed with prostate cancer in the USA this year and more than 30,000 will die of this disease. Androgen deprivation, the elimination of testosterone and its active metabolites, remains the single most effective intervention available for the treatment of advanced prostate carcinoma. This is usually achieved by surgical removal of the testes (orchiectomy), by suppressing production of testosterone (LHRH agonists) and/or by blocking the androgens at receptor sites (antiandrogens). Unfortunately, androgen suppression does not cure the disease. Most patients progress within 0-5 years, and all patients ultimately progress if the cancer is not eliminated during initial therapy (usually prostatectomy or radiation). Hormone suppression treatment eliminates the detectable levels of testosterone in the blood. However, the testosterone levels in tissue remain high enough to stimulate androgen receptors. Overexpression of androgen receptors is present in all cell lines which demonstrate "androgen independence," i.e., are resistant to androgen-suppressive therapy. Approximately 95% of testosterone is supplied by the testes, with the remaining 5% supplied by the adrenal glands. The presumption that standard androgen deprivation achieves the optimal level of androgen suppression for patients is based on the levels of androgen which result from orchiectomy. However, because adrenal androgen levels are unaffected by standard modes of androgen deprivation, 5% of the body's testosterone remains despite hormone therapy. The hypothesis of this study is that more effective suppression of the androgen axis through elimination of adrenal androgens and more effective suppression of testosterone metabolites will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and augmenting natural cell death (apoptosis). The investigators propose to test this hypothesis by administering neoadjuvant (pre-surgery) androgen deprivation therapy of different types before prostatectomy for patients with clinically localized prostate cancer. The investigators will assay serum and intraprostatic androgen levels, while assessing relative levels of apoptosis of normal and malignant tissue. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer 1248 http://clinicaltrials.dfhcc.harvard.edu/trials/1248 AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer The primary objectives of this study are the following: Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC) Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer 1261 http://clinicaltrials.dfhcc.harvard.edu/trials/1261 Intermittent Chemotherapy With or Without GM-CSF for Metastatic HPRC This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF therapy. The GM-CSF group dose schedule will be 250 mcg/m2 SQ daily Days 15-28 every 28 days. Patients in both groups will continue until disease progression at which time GM-CSF will be discontinued and chemotherapy will again be administered. Recruiting 24 Prostate Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/24-prostate-cancer